Library

Simplified rAAV Lysate Purification for Complex Analytics of Upstream Samples

Explore the CIM® SO3 0.2 mL Monolithic 96-well Plate's role in optimizing rAAV upstream production. Learn how Sartorius BIA Separations and BridgeBio Gene Therapy's approach expedites AAV analytics and reduces process development costs, achieving high capsid recovery and offering a cost-effective alternative to traditional purification methods.

Optimizing AAV and LV Purification and Analytics: Accelerated High-Quality Processes using CIM® Monoliths and PATfix®

Explore Hana Jug's presentation from BPI East 2025 on optimizing AAV and LV purification using CIM® Monoliths and PATfix. Learn how these tools ensure high purity, effective impurity removal, and comprehensive sample analysis, enhancing efficiency and quality in biopharmaceutical production.

pH Denaturation of dsRNA: A Novel Approach to mRNA Purification

A novel method improves mRNA purity by targeting dsRNA hydrogen bonds, enhancing chromatographic differentiation and cellular potency.

Efficient pDNA and mRNA Purification With Our Simplified Processes

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Viral Clearance in a Downstream AAV Process: Case Study Using a Model Virus Panel and a Noninfectious Surrogate

Michael Winkler, Mikhail Goldfarb, Shaojie Weng, Jeff Smith, Susan Wexelblat, John Li, Alejandro Becerra, Sandra Bezemer, Kevin Sleijpen, Aleš Štrancar, Sara Primec, Romina Zabar, April Schubert, Akunna Iheanacho, and David...

Column Integrity Test for CIM Monoliths

The column integrity test must be performed before first use and is the recommended test when column damage is suspected. Column integrity is evaluated with a pulse-response test, which measures...

2025 Sartorius BIA Separations' Newsletter Archive

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2025 Highlights & Sneak Peek at New Products for 2026

Discover new high reproducible CIMmultus PrimaS HR chromatographic columns.

Quick Guide for Purification of mRNA With CIM® Octa Oligo dT Columns

This method guide describes the use of CIM® Octa Oligo dT columns for the purification of mRNA. The document is designed to assist in use of the columns for automated...

An Efficient, End-to-End Process for Plasmid DNA Purification

This document details a case study on pDNA purification, achieving >98% supercoiled pDNA with high yield, purity, and regulatory compliance.

Robust and Scalable AAV8 Purification: A Two-Step Monolithic Chromatography Process

F. Bollmann, M. Noverraz, G. Pressac Abstract This study explores monolithic chromatography as an alternative to conventional resin- and ultracentrifugation-based methods for purifying adeno-associated viruses (AAVs). Leveraging monoliths’ convective mass...

An Efficient End-to-End AAV8 Platform Process at 50 L Scale

This application note presents an end-to-end AAV production platform covering upstream and downstream processing exclusively using Sartorius technologies. In upstream processing, HEK293 cells were seeded from a 10 L rocking...

Optimization of Preparative-Scale mRNA Capture Using Small-Scale Oligo dT Affinity Monoliths

Optimize mRNA dynamic binding capacity using CIMmic Oligo dT discs, which couple oligo-deoxythymidilic acid probes to monolith surfaces for selective mRNA binding. This study highlights the reduction in sample consumption and increased DBC from 1.9 mg/mL to 6.8 mg/mL through flow rate and buffer composition optimization, making CIMmic discs invaluable in early development.

Datasheet | PATfix LNP Switcher Platform

The PATfix® LNP Switcher Platform is an innovative solution for LNP analysis in process development. PATfix® LNP Switcher Platform is an all-in-one chromatographic platform that enables one-step analysis of lipid...

PrimaS HR: Setting New Benchmarks in Chromatography

Discover new high reproducible CIMmultus PrimaS HR chromatographic columns.

Introducing CIM® Ray Sterilized Columns with Aseptic Connector

Discover new high reproducible CIMmultus PrimaS HR chromatographic columns.

Datasheet | CIM® Ray QA

Sterilized, Single-Use Columns with Aseptic Connector CIM® Ray QA columns are strong anion exchange (AEX) sterile, single-use preparative columns designed for efficient bioprocessing of large biomolecules. Each column is sterilized...

Orthogonal PAT Analytics – Essential to Enable Robust Production of Viral Vectors and LNPs

Explore the challenges and innovative solutions in lipid nanoparticle (LNP) drug delivery, focusing on targeted LNPs (tLNPs) and the use of PATfix LNP Switcher for robust analytics and process development.

Modulating and Understanding Retention of Proteins on Chromatographic Support by Changing Cation-Exchanging Ligand

This study compares protein separation using CIM SO3 and CIM SO4 monolith cation exchangers, highlighting differences in elution under an ascending salt gradient. Through thermodynamic analysis, it explores how sulfonate and multimodal sulfate ligands affect retention and adsorption of lysozyme and cytochrome c, demonstrating CIM SO4's enhanced selectivity and potential as a tool for challenging protein separations.

AAV Capsid Separation Case Studies on CIM PrimaS® (HR) Monoliths

Impact of chromatographic deviations on AAV capsid separation with PrimaS® and PrimaS® HR, focusing on reproducibility and consistent elution profiles.

mRNA Production in GMP-Compliant Biostat® RM Systems

Discover how the PATfix® mRNA Platform optimizes GMP-compliant mRNA production, ensuring precise monitoring and control.

Full AAV Enrichment with CIMmultus PrimaS® HR

CIMmultus PrimaS® HR for AAV enrichment, combining hydrogen bonding with weak anion exchange, ensuring high reproducibility, advanced impurity removal, and high recovery rates for all AAV serotypes.

Advancing Nucleic Acid Therapeutics: Scalable Strategies for pDNA, mRNA, and LNP Purification Supported by Rapid At-Line Analytics

Explore Hana Jug's presentation from BPI East 2025 on optimizing AAV and LV purification using CIM® Monoliths and PATfix. Learn how these tools ensure high purity, effective impurity removal, and comprehensive sample analysis, enhancing efficiency and quality in biopharmaceutical production.

Next-Gen LNP Pharmaceuticals Analytics: Intact Chromatography for Comprehensive Characterization

Discover innovative chromatography techniques for LNP pharmaceuticals, focusing on comprehensive characterization and process optimization.

Streamline Small-Scale Purification: Efficient Solutions for Nucleic Acid & Viral Vector Separation

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Accelerating AAV Processing: Scalable, Serotype-Agnostic Process Eliminating 2-steps (DNase and TFF) and Optimized for Physiological-Like Conditions

This study proposes a streamlined alternative to traditional AAV downstream processing, focusing on reducing the number of steps while simultaneously improving both recovery and process efficiency. We demonstrate a novel approach comprising just five integrated steps shown to work on various serotypes (AAV2, AAV8, AAV9).

Efficient Removal of Activated Coagulation Factor XI (FXIa) from Cohn Fraction II Paste Using Mixed Mode Ligand

Factor XI (FXI) is the zymogen of a serine protease, Factor XIa (FXIa). It is a 160 kDa protein, with an average plasma concentration of 3 to 7 µg/ml. Its...

A Novel Approach for dsRNA Removal Using Oligo dT Affinity Chromatography by Targeting Hydrogen Bond

Explore Hana Jug's presentation from BPI East 2025 on optimizing AAV and LV purification using CIM® Monoliths and PATfix. Learn how these tools ensure high purity, effective impurity removal, and comprehensive sample analysis, enhancing efficiency and quality in biopharmaceutical production.

Reproducibility of CIMac QA HR Columns

This application note showcases the reproducibility of quaternary amine-based analytical monolithic columns. CIMac QA HR enables superior separation and analysis of empty and full AAV capsids.

Purification of mRNA With CIM® Oligo dT Monolithic 96-well Plate

Optimize your mRNA purification with our comprehensive guide on CIM® Oligo dT Monolithic Well Plates. Designed to assist in screening multiple mRNA constructs, this document provides detailed instructions for experiment setup, sample preparation, and buffer usage. Explore chromatographic conditions for seamless transfer to preparative CIMmultus® Oligo dT columns, with insights on plate size variants for flexible and adaptable purification processes.

Removing dsRNA with Oligo dT | A Novel Approach for High-Purity mRNA

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The Impact of Chemical Reactivity on the Quality and Stability of RNA–LNP Pharmaceuticals

Explore the chemical complexity of RNA-LNP formulations crucial for mRNA therapies. This study highlights the role of Sartorius BIA Separations' PATfix LNP Switcher and CIM monolithic columns in detecting chemical impurities and enhancing RNA-LNP characterization. Discover how advanced analytical tools like RP-IP-LC and mass spectrometry, along with CIM OH and SDVB columns, improve encapsulation efficiency, size determination, and resolution between RNA species, supporting the development of stable and high-quality RNA-LNP pharmaceuticals.

Comprehensive Evaluation of RNA Integrity, Nanoparticle Properties, and Lipid Composition in RNA LNP

Explore Hana Jug's presentation from BPI East 2025 on optimizing AAV and LV purification using CIM® Monoliths and PATfix. Learn how these tools ensure high purity, effective impurity removal, and comprehensive sample analysis, enhancing efficiency and quality in biopharmaceutical production.

HPLC Fingerprinting Approach for Raw Material Assessment and Unit Operation Tracking for IVIG Production From Cohn I+II+III Fraction

Sebastijan Peljhan, Tina Jakop, Dunja Šček, Vid Skvarča, Blaž Goričar, Romina Žabar, Nina Mencin Electrophoresis, Volume38, Issue22-23, Special Issue: Monoliths The plasma-derived IgG used either for diagnostic purpose or intravenous...

Monolith Based Chromatography Is a Suitable Tool to Prepare and Analyze E. coli – Outer Membrane Vesicles

Explore the collaborative study with NecstGen on developing a scalable, GMP-ready DSP platform for lentiviral vector (LV) gene therapies. Utilizing Sartorius BIA Separations' CIM QA and DEAE Monolithic 96-well plates and CIMmultus QA columns, the study achieved significant improvements in DSP yields, reducing manufacturing costs. Discover how Design of Experiments (DOE) methodologies enhanced process understanding and LV recovery, optimizing purification efficiency and product quality for cost-effective gene therapy solutions.

Collaborative Development with NecstGen: Scalable GMP-Ready LV DSP Platform

Explore the collaborative study with NecstGen on developing a scalable, GMP-ready DSP platform for lentiviral vector (LV) gene therapies. Utilizing Sartorius BIA Separations' CIM QA and DEAE Monolithic 96-well plates and CIMmultus QA columns, the study achieved significant improvements in DSP yields, reducing manufacturing costs. Discover how Design of Experiments (DOE) methodologies enhanced process understanding and LV recovery, optimizing purification efficiency and product quality for cost-effective gene therapy solutions.

Ebook: PATfix pDNA Analytical Platform for Rapid Monitoring and Optimization of pDNA Production Process

Nejc Pavlin, Blaž Bakalar, Janja Skok, Špela Kralj, Andreja Gramc Livk, and Aleš Štrancar BioProcess International, October 2021 Abstract: Plasmid DNA (pDNA) has become a crucial component in the production...

Scale-up of Plasmid DNA Downstream Process Based on Chromatographic Monoliths

U. Černigoj, A. Štrancar DNA Vaccines. Methods in Molecular Biology, vol 2197, pp 167-192 Abstract: Purification of high-quality plasmid DNA in large quantities is a crucial step in its production...

Achieving Scalable, High-Yield Plasmid DNA Purification Processes

Explore our recorded webinar on overcoming bottlenecks in plasmid (p)DNA downstream processing. Learn optimization strategies for lysis to sterile filtration, achieving high yield, purity, and compliance. Discover case studies showcasing integrated pDNA purification with real-time process monitoring and at-line analytics for enhanced performance and quality assurance.

Virtual Event: Addressing Challenges in pDNA, mRNA, and LNP Development, CMC, and Production

Access the recordings of our virtual event addressing challenges in pDNA, mRNA, and LNP development, CMC, and production. Gain insights from leading experts like Dan Peer and Jacek Lubelski on gene expression modulation, RNA delivery, and LNP manufacturing. Explore scalable purification workflows, innovative approaches to gene editing, and advanced analytical techniques for therapeutic applications. Enhance your understanding of nucleic acid delivery and LNP complexity with practical solutions for overcoming CMC hurdles.

Advanced Solutions | From Optimized Capture for Any AAV Serotype to Precise Capsid Separation

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PATfix® pDNA Platform and PCR Methods as Orthogonal Analytical Tools for Quantification of pDNA

Poster presents a comparison of three orthogonal methods—PATfix® pDNA Platform, qPCR, and dPCR—for the quantification and characterization of plasmid DNA (pDNA) in gene therapy workflow. While PCR-based approaches provide total...

CIMmultus Oligo dT Affinity Column Based Extraction of mRNA From IVT Mixtures

The increasing demand for messenger RNA (mRNA) as a therapeutic product requires larger production scales and more efficient extraction techniques. In this poster, fast and efficient way to purify poly-adenylated...

Screening Binding Conditions on CIM Oligo dT 96-Well Plate to Optimize Dynamic Binding Capacity

Screening of chromatographic conditions to increase the binding of mRNA to OIigo dT and scale up to preparative CIM® monoliths

Datasheet | CIM®Monolithic Well Plates

This datasheet provides product information and specifications for CIM® Monolithic Well Plates, designed for high-throughput screening and purification of biomolecules. The datasheet guides you in selecting the appropriate monolith chemistry...

Monitoring Orf Virus Production with PATfix® Analytical Method

Orf virus (ORFV) is a promising vaccine vector candidate, capable of inducing a strong, long-lasting immune response without integrating into the host genome. Its broad host range and ability to...

Chromatographic Purification of LNP-based Formulations with CIMmultus® OH

Discover the chromatography-based purification of lipid nanoparticles (LNPs) using CIMmultus® OH monolithic columns. This method offers fast flow rates, minimal shear stress, and combines buffer exchange, ethanol removal, and LNP concentration in one run. Achieve higher recoveries, enhanced stability, and uniform size distribution compared to traditional techniques like TFF and dialysis, while reducing costs through column reuse.

Enhanced Separation of AAV Capsids Using Analytical Anion Exchange Monolithic Columns: Emphasis on Organic Modifiers

Discover high-resolution AAV capsid separation using CIMac QA HR columns and the PATfix system. Enhance gene therapy safety and efficacy with optimized techniques validated across multiple serotypes, offering a robust platform for precise characterization and reliable process development.

Optimizing AAV Purification: Comparative Evaluation of Three CIMmultus® Polishing Columns for Enhanced Vector Enrichment and Final Product Purity

The poster presents a comparative evaluation of three CIMmultus® polishing columns—QA HR, PrimaT, and PrimaS—in optimizing the purification of AAV vectors. Highlighting their unique strengths, the study reveals QA HR's...

High Throughput Screening (HTS) or Single-Column Approach for Improvement of Empty/Full Separation of AAV

Accelerate AAV development with a fast, reproducible polishing workflow that separates empty and full capsids across three scalable CIM® monolith formats - from 96 well plates to CIM® Octa and...

Webinar with Refeyn: AAV6 Capsid Optimization with CIM SO3 Plates & Mass Photometry

Speakers: Hena Divanovic, Application Scientist at Refeyn Marko Narobe, Product Manager for High Throughput Solutions at Sartorius BIA SeparationsWatch the webinar to learn how to: The use of CIM SO3...

Comprehensive Characterisation of Extracellular Vesicle Preparations Using Multiparametric Size-Exclusion Chromatography

Explore a comprehensive framework for extracellular vesicle (EV) characterization using size-exclusion chromatography (SEC) integrated with absorbance, fluorescence, and light scattering detection. Discover how the PATfix® Chromatography System enhances EV analysis, improving quality control and reproducibility in research and therapeutic applications. Learn about critical factors for assay robustness, including mobile phase composition and immunolabelling parameters, optimized by this advanced system.

Nucleic Acid Development, CMC, and Production of In-vivo Crispr, CAR-T and similar

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Enhanced Monitoring of AAV Downstream Processes Using Liquid Chromatography Approaches

In-process control of AAV downstream processes (DSPs) ensures process efficiency, product quality, safety and consistency . Using liquid chromatography (LC)-based methods such as size exclusion chromatography (SEC), cation exchange (CEX),...

Exploring Chromatographic Parameters for AAV Capture Step with CIMmultus SO3

This application note explores the impact of various parameters on the performance of the CIMmultus® SO3 column. CIMmultus SO3 is a strong cation exchanger (CEX) that binds molecules with a...

Advancements in Lentiviral Purification: From High Throughput Screening to Scalable Solutions

Lentiviral vectors are being increasingly used as tools for stable integration of large gene inserts into the genomes of both dividing and non-dividing cells. With 3rd and 4th generation of...

Integrating Upstream and Downstream Processes for Enhanced Purity and Yield of Adenovirus 5

The document describes a streamlined adenovirus (AdV) production process that integrates optimized upstream methods with a scalable downstream purification strategy. Using suspension HEK cells and a single chromatographic step on...

A Better Way to Purify LNPs: Higher Recovery & Uniform Particles

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Accessible Chromatography Solutions to Support Your Innovation

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Analysis of LNPs Using 2D Chromatography: Simultaneous Determination of Encapsulation Efficiency, Nucleic Acid Integrity, and Size of LNP Formulations

Nejc Pavlin, Mojca Bavčar, Tristan Kovačič, Tjaša Kašček, Anže Martinčič Celjar, Ines Bergoč, Andreja Gramc Livk, and Aleš Štrancar  Journal of Chromatography B, Volume 1265, 2025. Abstract: Lipid nanoparticles (LNPs)...

End-To-End Process for Improved Purity, Combined With Innovative Analytics of LNP-Based Therapeutics

This poster presents a comprehensive approach to optimizing the mRNA-LNP production process, focusing on key steps from plasmid DNA expression in E. coli to encapsulating nucleic acids into lipid nanoparticles...

Monoliths for a Novel, Selective and High-Recovery Purification Process of LNP-Based Biopharmaceuticals

CIMmultus OH monolithic columns can be utilized as a chromatographic solution to purify LNPs. This process is used as a direct alternative to existing processes like TFF or dialysis, but...

Discover pDNA, mRNA, and LNP Breakthroughs: Slovenia Event, Webinars, and More!

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CIM® Swiper for Comprehensive RNA Purification

CIMmultus Swiper is a chromatography column designed for efficient nucleic acid purification in a near-neutral pH range. Follow this method guide to purify mRNA

AAV Capture Step with CIMmultus SO3

CIMmultus SO3 is a monolithic chromatographic column with SO3 (Sulfonate), a strong cation-exchanger that binds positively charged molecules and repels negatively charged ones across all pH levels. It effectively binds...

Strategies for Improving LNP Functionality & Addressing Development, CMC and Manufacturing Challenges

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Method Optimization & High Throughput Purification for mRNA and rAAV

Speaker: Marko Narobe, Sartorius BIA SeparationsAbstract: The downstream processing of virus particles, vesicles, RNAs, plasmids and other forms of DNA, contains multiple interdependent steps, each requiring optimization for best results....

Optimization of In vitro Transcription Reaction for mRNA Production Using Chromatographic At-Line Monitoring

Tina Vodopivec Seravalli, Janja Skok, Tjaša Marušič, and Rok Sekirnik J. Vis. Exp. 2025 Apr 4:(218). doi: 10.3791/67503 The article presents a method for optimizing the in vitro transcription (IVT) reaction, which...

Optimize AAV Purification: From Capture to Effortless Control With PATfix

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Transform Your Biomanufacturing with Cornerstone Services

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Maximize AAV Purification Efficiency with Our Solution

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Discover CIMmultus® PrimaT for Multimodal AAV Purification

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Introducing CIMmultus Swiper: Revolutionizing RNA Purification

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Innovations in pDNA | mRNA | LNP Development and Manufacturing: Expert Perspectives and Networking Opportunities

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All-in-One Tool for Studying & Analyzing Complex LNP Formulations: PATfix LNP Switcher Platform

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Introducing Alkalizator | The Future of Automated In-Line Lysis

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Discover Scalable Chromatography Solutions for Process Development and Optimization

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New Product Alert | In-line Lysis System & LNP Analytical Platform

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Introducing PATfix® AAV Switcher Platform | CIM® Octa Miniaturized Columns & More

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Join Us in Slovenia: Test Your pDNA, mRNA and LNP Samples and Learn from the Best

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The Importance of Viral Clearance and Characterization in Gene Therapy Products

Speakers: Ya-Chen Chang, Regenxbio Akunna Iheanacho, Texcell Katelyn Pritchard, Texcell Maja Leskovec, Sartorius BIA Separations Maja Leskovec, Head of Process Development Viruses at Sartorius BIA Separations, presented "High Resolution Chromatography...

Advancing EV Research: Analytical Chromatography Solutions for Efficient and Comprehensive Characterization of EV Preparations With Varying Complexity

Speakers: Darja Božič, Project Manager, Sartorius BIA SeparationsAbstract: The field of extracellular vesicles (EV) has been increasingly empowered in recent decades, with significant advances in sophisticated analytical tools and the...

Efficient rAAV8 Capsid Quantification in Upstream Process Development With Two-Dimensional Liquid Chromatography

Obtaining a high concentration and a significant proportion of full recombinant adeno-associated viruses (rAAV) capsids during production is important for the success of the entire AAV bioprocess. Analyzing complex upstream...

Immobilized Enzyme Reactors on Monoliths: A Platform For Efficient pDNA Linearization

Immobilized enzyme reactors (IMERs) on monolithic supports were developed for efficient plasmid DNA linearization, a critical step in mRNA production. EcoRI, NdeI, and HindIII were successfully immobilized, achieving comparable linearization...

Datasheet | PATfix AAV Switcher Platform

The PATfix® AAV Switcher Platform is an advanced analytical solution that leverages established liquid chromatography techniques to provide a comprehensive analysis and control of USP samples. It enables accurate estimation...

Exploring Chromatographic Parameters for Enhanced Full AAV Enrichment With CIMmultus® PrimaT

This application note explores the impact of various parameters on performance of CIMmultus® PrimaT column to optimize initial recommended methods, tailoring them to user’s specific AAV sample for enhanced enrichment...

Poster by Genethon | Full AAV8 Capsid Enrichment Step with the CIMmultus® PrimaT

Development of a Full Capsid Enrichment Step in the Purification Process of an AAV8 Product by the CIMmultus® PrimaT Monolith With CIMmultus PrimaT extremely consistent full AAV enrichment &...

Optimizing Plasmid DNA Purification | Webinar with VGXI

Speakers: Christy Franco, Director, Commercial Operations at VGXI Jasmina Puc, Product Manager for Nucleic Acids at Sartorius BIA SeparationsWatch the webinar to learn how to: Enhance robustness and improve contaminant...

Poster by Genethon | Full AAV9 Capsid Enrichment Step with the CIMmultus® PrimaT

Development of Full Capsid Enrichment Step in AAV Purification Process with CIMmultus® PrimaT Monolith CIMmultus PrimaT demonstrates efficient separation of empty and full AAV capsids even from AAV9 serotype....

Lentiviral Downstream Process Optimisation and Design of Experiments on CIM QA 0.05 mL Monolithic 96-Well Plates

Lentiviral vectors are being increasingly used as tools for stable integration of large gene inserts into the genomes of both dividing and non-dividing cells. With 3rd and 4th generation of...

Comparing Cation-Exchange Monolith and Affinity Resin for Chromatographic Capture and Purification of rAAV

This study evaluated the purification efficiency of the CIMmultus SO3 column compared to two commercially available affinity resins for Adeno-Associated Virus (AAV) purification. AAV material was prepared using two distinct...

Purification of mRNA With CIMmultus Oligo dT

The ligand in CIM Oligo dT18 is an 18-mer deoxythymidine chain covalently immobilized on the monolith with a carbon linker. RNA with a poly(A) tail binds on the ligand by...

Purification of mRNA With CIMmultus C4 HLD

The ligand in CIM C4 HLD monoliths is a hydrophobic butyl group. RNA binds on the column under hydrophobic conditions. The majority of DNA and short transcripts elute earlier than...

Purification of mRNA With CIMmultus SDVB

CIM SDVB is a polystyrene divinylbenzene monolith used for reversed phase (RP) purification of large biologics. It is used in purification of nucleic acids for size fractionation. In addition to...

Basic Principles for the Best Results With pFix5 Standard

This procedure describes the experimental materials and methods to perform analysis for standard curve with the pFix5 standard.

Basic Principles for the Best Results With pFix15 Standard

This procedure describes the experimental materials and methods to perform analysis for standard curve with the pFix15 standard.

Basic Principles for the Best Results With mFix4 mRNA Standard

mRNA standard can be used for three complementary analytics: Oligo dT (affinity chromatography with CIMac Oligo dT column), PrimaS (bimodal anion exchange and hydrogen bonding with CIMac PrimaS column) and...

AAV Full Capsids Enrichment With CIMmultus QA HR

CIMmultus QA HR column is anion exchange chromatography monolithic column. One of its main applications is enrichment of AAV full particles. Empty and full AAV capsids have small difference in...

Specimen QA HR Method Guide

Specimen unit is small volume device shipped together with CIMmultus QA HR chromatography column. Specimen use is not a prerequisite for running the CIMmultus QA HR column, but it can...

Datasheet | PATfix AAV Analytical Platform

The PATfix® AAV platform offers comprehensive analysis and control of the downstream purification process (DSP) samples, ensuring improved efficacy, safety, and purity of the final viral vector products. By monitoring...

Enhancing Manufacturing Efficiency and Quality Through Optimized Lysis in Plasmid DNA Extraction

Speakers: Robin Pelizzari, Scientist pDNA small scale DSP Development, mRNA Center of Excellence at Sanofi Vaccine, France Matevž Korenč, Product Manager at Sartorius BIA Separations, SloveniaWatch the webinar to learn...

Accelerate Your AAV Process Development With a New Wave Analytical Tool

Speaker: Andreja Gramc Livk, Sartorius BIA SeparationsAbstract: Adeno-associated viruses (AAVs) are widely used vectors for gene therapies mainly due to their favorable safety profile and high transduction efficiency to various...

Enrichment of Full AAV With CIMmultus PrimaT

CIMmultus® PrimaT is a monolithic chromatography multimodal column, mainly used to enrich full AAV enrichment. Separation is based on weak anion exchange, H-bond and metal affinity coordination interactions with the...

Purification of rAAV With CIM SO3 Monolithic 96-Well Plate

CIM® Monolithic Well Plates offer robust and reliable screening of multiple chromatographic conditions or high-throughput purification of large biomolecules like viruses and nucleic acids. Presented method describes quick and simple...

Manufacturing Platform – From pDNA and mRNA to LNP With Multiple Nucleic Acids Loads

The typical mRNA production process is a complex sequence of four key steps, each crucial for ensuring the quality and efficacy of the final product. The process begins with the...

Cornerstone Biomanufacturing Development Services

Cornerstone® Biomanufacturing Development Services are the result of our more than 20 years of hands-on expertise with the most challenging biopharmaceutical products and offer a combination of process development solutions...

Comparability Study Between Ion-Exchange Monolith and Affinity Resin For Purification of AAV8

The main objective of every downstream process (DSP) for AAV is to achieve high recovery while delivering the purest, most potent product possible. The capture step in AAV gene therapy...

A Chromatographic Tool to Comprehensively Characterize Complex Novel RNA-LNP Drug Products

To address challenges in LNPs characterization, we have developed a method capable of simultaneously evaluating key parameters of the LNP formulations.

Common Properties of Extracellular Nanoparticles From Various Sources: Utilizing Chromatography for a Comprehensive Characterization of Complex Samples

Challenges in achieving high purity preparations and limitations in established analytics remain a rudimentary burden in studies of extracellular vesicles (EVs) and their biological roles. A good understanding of preparations’...

mRNA | saRNA Process Development With PATfix Analytical Platform

Recent advancements in mRNA-based vaccines and therapeutics have simplified production compared to traditional vaccines, enabling rapid large-scale output. The process involves in vitro transcription (IVT) and chromatographic purification, requiring effective...

Monolithic Columns for a High Recovery Purification Process of RNA-LNP Vaccines and Therapeutics

To address challenges in LNPs characterization, we have developed a method capable of simultaneously evaluating key parameters of the LNP formulations.

Advancing AAV Analytics: Post-DGUS Profiling as a Robust Tool for AAV Capsid Characterization

Density gradient ultracentrifugation (DGUC) is a well-established method for separating empty (E) and full (F) AAV capsids based on density differences. However, traditional DGUC is labour-intensive and lacks direct detection...

Applicability of CIM Protein G 96-Monolithic Plate for Glycosylation Analysis of Human IgG Isolated From Blood

Chromatographic applications in diagnostics call for automated systems and high-throughput analyses in order to cope with the large numbers of samples. Sartorius BIA Separations offers differently modified monoliths (ion exchanging,...

Development and Validation of AAV Capsids Separation on Specimen Columns for Reproducibility Evaluation of Large-Scale Chromatographic Monoliths

Rok Miklavčič, Tina Simčič, Sara Rotar, Polona Komel, Rok Žigon, Dona Pavlovič, Ines Bergoč, Domen Ipavec, Ana Simčič Zuljan, Ažbe Žnidaršič, Dolores Kukanja, Jana Vidič, Aleš Štrancar, Urh Černigoj Journal...

Reverse-Phase Chromatography Removes Double-Stranded RNA, Fragments, and Residual Template to Decrease Immunogenicity and Increase Cell Potency of mRNA and saRNA

A. Krušič, N. Mencin, M. Leban, E. Nett, M. Perković, U. Sahin, P. Megušar, A. Štrancar, and R. Sekirnik Molecular Therapy Nucleic Acids, Volume 36, Issue 2, 2025 Abstract: mRNA...

AAV Capsid Analysis and Quantification With Chromatography and Ultracentrifugation-Based Techniques

Speakers: Andreja Gramc Livk, Head of Process Analytics, Sartorius BIA Separations Sebastijan Peljhan, Head of Basic Research, Sartorius BIA SeparationsAbstract: This webinar will explore empty-to-full AAV capsid ratio determination using...

In-Line Lysis System: The Easiest Alternative to Batch Alkaline Lysis

Speaker: Matevz Korenc, Product Manager, Sartorius BIA SeparationsAbout the Speaker After receiving a PhD in Biochemistry, Matevz Korenc continued as a team leader in Knauf insulation, where he managed the...

Advancing LNP Characterization for Drug Delivery: NeoVac

Speakers: Blaž Bakalar, Product Manager, PATfix® Platform, Sartorius BIA Separations Dan Peer, Chairman, NeoVac Tristan Kovačič, Scientist, Process Analytics Development, Sartorius BIA Separations Abstract: Lipid nanoparticles (LNPs) are cell-specific delivery...

2024 Sartorius BIA Separations' Newsletter Archive

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Quantitative Analysis of Lipids and Nucleic Acids in Lipid Nanoparticles Using Monolithic Column

Nejc Pavlin, Mojca Bavčar, Tristan Kovačič, Tjaša Plesničar, Andreja Gramc Livk, Aleš Štrancar Cell & Gene Therapy Insights 2024; 10(6), 867–878 Lipid nanoparticles, a promising platform for drug delivery, effectively...

Optimizing LNP Formulations: Leveraging Monolithic Columns for Precise Insight and Improvement Strategies

Watch this webinar to learn about: How to capitalize on the advantages of scalable methods for separation of different biomacromolecules Understand the benefits of highly tunable chromatographic methods Discover how...

Monolithic Columns Enable Streamlined Downstream Processing and Analytics of Lipid Nanoparticles

Lipid nanoparticles are leading non viral carriers for therapeutics, offering versatility in encapsulating diverse payloads. Their manufacturing superiority over viral systems allows for modularity, speed, and scalability. However, this modularity...

Datasheet | PATfix pDNA Analytical Platform

Global demand for pDNA production is at an all time high, due to increased need from Gene Therapy ramp-up. pDNA, as an enabling product, is critical in production of mRNA,...

Datasheet | PATfix mRNA Analytical Platform

PATfix analytical system is all it takes to accelerate your process development and have continuous at-line production monitoring and robust quality control of nucleic acid drug substances. Designing a correct...

2D-LC Evaluation of Complex Samples Containing Extracellular Vesicles

The aim of the study was the development of a robust and high-throughput method that would enable a comprehensive evaluation of extracellular vesicles (EVs) in complex samples. Our goal was...

A Year of Success: Breakthroughs, Partnerships, and New Year Wishes

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FastFacts: PATfix pDNA Platform for Monitoring pDNA Purification Process

Watch the video or read the poster to learn: The importance of pDNA as an enabling product in the production of mRNA, AAV, and other therapeutic vectors How the PATfix™...

Neural Stem Cell-Derived Extracellular Vesicles Purified by Monolith Chromatography Retain Stimulatory Effect on in Vitro Scratch Assay

Ivano Luigi Colao, Randolph L. Corteling, Daniel G. Bracewell, Ivan B. Wall Cytotherapy 2024 Abstract: Extracellular vesicles (EVs) have emerged as promising cell-free therapeutic candidates. A key focus of EV...

mRNA Production at WACKER | Analytics From pDNA to LNP Formulation

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Optimizing Lentiviral Purification: Enhancing Chromatography With Monoliths

Speaker: Luka Bevc, Manager Product|Application Area, Sartorius BIA SeparationsAbstract: Lentiviral vectors (LVVs) can effectively deliver up to 10 kb of target genes and can infect non-dividing cells, making them a...

Quality by Design in mRNA Manufacturing: At-Line Monitoring Coupled With DOE for Higher IVT Yield and Efficiency of Purification

Speaker: Rok Sekirnik, Head of Process Development for mRNA and pDNA, Sartorius BIA SeparationsAbstract: Due to the catalytic, multicomponent nature of the IVT reaction, optimization is a multi-factorial problem, ideally...

Enhancing mRNA Production with Advanced Analytics: WACKER Biotech

Speakers: Blaž Bakalar, Product Manager, PATfix® Platform, Sartorius BIA Separations Michael Daume,Group leader, Downstream Process Development for Nucleic Acids, WACKER BiotechAbstract: Production of mRNA involves complex IVT mixtures, including target...

Accelerating AAV Process Development: NCSU BTEC

Speakers: Blaž Bakalar, Product Manager, PATfix® Platform, Sartorius BIA Separations Shriarjun Shastry (Arjun), Scientist II, Biomanufacturing Training and Education Center (NCSU BTEC)Abstract: Adeno-associated viruses (AAVs) are widely used vectors for...

Implementation of an Improved Platform for Downstream Processing of Plasmid DNA

Speakers: Justina Martinkiene, Scientist, Purification Sciences, AstraZeneca Klemen Božič, Process Development Scientist, Sartorius BIA SeparationsAbstract: Plasmid DNA (pDNA) represents the backbone of most cell and gene therapy production workflows. As...

Comparability of Five Alternative AAV9 Downstream Processes from Ultracentrifugation to Chromatography

Speakers: Aleš Štrancar, Executive Managing Director, Sartorius BIA Separations Joe Balleydier, Senior Vice President of Research and Development, Advanced Medicine Partners Mike Hatfield, Senior Director of Research and Development, Advanced...

Improving the Safety of Your LNP-mRNA Therapeutics and Vaccines by Utilizing Monolithic Chromatography

Speakers: Andreja Gramc Livk, Head of Process Analytics Tristan Kovačič, ScientistLipid nanoparticle (LNP) based therapeutics and vaccines have been at the forefront of the non-viral delivery since SARS-CoV-2 vaccines rolled...

Process is the Product: A New Analytical Tool for AAV Production Optimization and Monitoring

Speakers: Blaž Bakalar, Product Manager PATfix® Platform, Sartorius BIA Separations Ivana Petrović Koshmak, Head of Upstream Process Development, Sartorius BIA SeparationsAbstract: Chromatographic analysis of complex AAV presents challenges due to...

Mastering Monolith Chromatography with DOE Strategies for Lentiviral Vector and Exosome Purification

Speakers: Maja Leskovec, Head of Process Development Viruses Luka Bevc, Scientist Andrej Raspor, ScientistAbstract: Join us for an insightful webinar on the latest advancements in monolith chromatography for lentiviral vector...

HPLC for At-Line Reaction Monitoring and Purification Improves Yield and Purity of tRNA

Megušar Polona , Calder Ewen D. D. , Vodopivec Seravalli Tina , Lebar Sergeja , Walport Louise J. ,  and Sekirnik Rok Frontiers in Molecular Biosciences, 11. September 2024. Abstract...

Development of a Dual-Stage CIM® CDI Reactor with Immobilized Glucuronan Lyases and Laccases for Sustainable Synthesis of Antioxidant Phenolized Oligoglucuronan

Xiaoyang Hou, Pascal Dubessay , Gwendoline Christophe, Nicolas Bridiau, Pierre-Edouard Bodet, Mounir Traikia, Mugilan Damadoran Raja, Thierry Maugard, Aleš Štrancar, Fabrice Audonnet, Philippe Michaud, and Guillaume Pierre Polysaccharides 2024, 5(4), 743-760 Abstract:...

Improving the Manufacture of mRNA Biologics

Josh P. Roberts Genetic Engineering & Biotechnology News, November 15, 2024. Abstract:  The COVID-19 pandemic has accelerated interest in mRNA technologies, particularly in improving the manufacturing processes for mRNA-based vaccines....

New Techniques for Viral Vector and RNA Production

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Transferring EV Purification Process from CIMmultus EV to QA HR Column

CIMmultus EV, an anion exchange column intended for the purification of extracellular vesicles and CIMmultus QA HR, a novel column from the CIM® QA HR line, designed for the highest...

Save the Date: 11th MSS is Coming to Bled in 2026!

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Targeted Optimization of AAV8 Upstream Process for Enhanced Downstream Performance

Several recombinant AAV (rAAV)-mediated therapies have been approved so far, and many more are in clinical trials, yet developing an efficient rAAV process platform remains a challenge. First obstacle arises...

Customer Spotlight: Arik Makovitzki on Phage Innovations

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Transform Analytics in Your Process Development | Join Online

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Expert Webinars on Biopharmaceutical Process Optimization

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Using Monolith Chromatography to Purify Phages

Ažbe Žnidaršič, Lucija Rebula Capsid & Tail, 282. September 2024. Abstract Phage purification presents unique challenges due to the complex nature of these viruses and the need for high purity in...

Sartorius BIA Separations In-Line Lysis System

Discover a new solution by Sartorius BIA Separations for efficient plasmid DNA isolation. A fully automated in-line lysis system with a closed single-use loop streamlines GMP-scale process development. It handles...

New Advances in AAV and Exosome Purification

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Purification of mRNA With CIMmultus PrimaS

The ligand in CIM PrimaS contains a series of hydrogen donors and hydrogen acceptors, combined with a weak anion exchange character. Its hydrogen bonding ability makes its selectivity entirely distinct...

Transform Your Biopharmaceutical Workflows with Innovative Solutions

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AAV Capsids Separation Is Critical for Advancing Gene Therapies

Timotej Žvanut, Andreja Gramc Livk, Aleš Štrancar Cell & Gene Therapy Insights 2024; 10(3), 503–511 AAVs are widely used vectors in gene therapy. During the process of AAV viral vectors...

MSS2024 Attendees Talk About Sartorius BIA Separations

Chris Dilmore | Charles River Laboratories Chris is a member of the process development team at Charles River Laboratories. His primary focus is downstream innovation work focused on automation, TFF,...

Isolation of RAE-1 From Murine Cells Based on Immunoaffinity Monolithic Chromatography

Immunoaffinity columns using antibodies as ligands against mammalian proteins could be used for different applications in protein expression control and, if a standard available, for direct protein quantification in complex...

One-Step Purification of Research-Grade Single-Stranded mRNA

CIMac PrimaS is a new member of BIA’s family of high performance monoliths for analysis and purification of mRNA. Its positive charge gives it some anion exchange behavior but hydrogen...

Release Criteria for CIM® QA HR AAV Test

The most selective QC test for the release of CIM® QA HR chromatographic columns is a specific AAV test based on the results of AAV E/F separation performed in an...

Effective Endotoxin Reduction in Bacteriophage Samples Using CIMmultus Monolithic Technology

Endotoxins are robust and persistent impurity, which are native to majority of phage substrates. Two anion exchangers, CIMmultus PrimaS and H-Bond, were tested for their capacity for endotoxin removal in...

Quick Start Methods for pDNA Isoform Monitoring With CIMac pDNA

CIMac pDNA Analytical Column is powerful tool for pDNA quantification for in-process control or in a QC laboratory. The column can separate pDNA isoforms from each-other and from RNA impurities....

Grafting Chromatographic Monoliths With Charged Linear Polymers for Highly Productive and Selective Plasmid DNA Purification

Increased requirements for plasmid DNA (pDNA) in gene therapy and vaccination efforts brings the need for efficient large-scale production processes with high purity and productivity. Chromatographic purification of pDNA is...

Discover Ground-breaking Advances in Chromatography and Gene Therapy

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CIM Monolith: Purification of Nucleic Acid Molecules

A purification of synthetic oligonucleotides by using CIM monolith was evaluated. In this case study, the CIM anion exchange column had the capability to resolve oligonucleotides with small difference in...

Fast & Efficient rAAV Downstream Process Optimisation With CIM Monolithic 96-Well Plates

Speaker: Mojca Tajnik Sbaizero, Project Manager, Sartorius BIA SeparationsAbstract: rAAV downstream process using monoliths contains a series of steps that are mutually dependent. Therefore each step should be optimized for...

Fast and Semi-Automatic Optimization of Capture Step for rAAV Purification Using CIM SO3 96-Well Monolithic Plate

First chromatographic step in industrial platform using monoliths is a capture step, where rAAV is selectively bound to strong cation exchanger (SO3) in acidic pH conditions. In this step majority...

Chromatographic Monoliths for High-Throughput Immunoaffinity Isolation of Transferrin From Human Plasma

I. T. Akmacic,B. Nemec,U. Vidic, S. Malcic, K. Miklic, U. Cernigoj, J. Vidic, N. L. Krajnc, A. Strancar, G. Lauc, T. L. Rovis, M. P. Bakovic. Croat. Chem. Acta 2016,...

Quality by Design Approach to Improve Quality and Decrease Cost of in Vitro Transcription of mRNA Using Design of Experiments

Jimmy Boman, Tjaša Marušič, Tina Vodopivec Seravalli, Janja Skok, Fredrik Pettersson, Kristina Šprinzar Nemec, Henrik Widmark, Rok Sekirnik Biotechnology and Bioengineering Abstract: In vitro transcription (IVT) reaction is an RNA...

High Reproducibility, Homogeneity, and Scalability of CIM® QA HR Chromatographic Monoliths Demonstrated by Separation of Empty and Full AAV Capsids

One of the key challenges in adeno-associated virus (AAV) viral vector manufacturing is effective and consistent separation of full AAV particles (containing the full recombinant DNA of the gene of...

Rapid Desalting of E. Coli Cell Lysate for CGE Analysis Using Monolithic Spin Columns

Neutralized E. coli cell lysate is a complex intermediate sample in the production process of plasmid DNA (pDNA) for use in vaccines and gene therapy. It contains various amounts of...

Summer Biotech Breakthroughs Await!

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Purification and Basic Biochemical Characterization of 19 Recombinant Plant Peroxidase Isoenzymes Produced in Pichia Pastoris

F. W. Krainer, R. Pletzenauer, L. Rossetti, C. Herwig, A. Glieder, O. Spadiut Protein Expression and Purification 95 (2014) 104–112 The plant enzyme horseradish peroxidase (HRP) is used in several...

Yeast Virus-Derived Stimulator of the Innate Immune System Augments the Efficacy of a Viral-Vector Based Immunotherapeutics

M.-C. Claudepierrea, et al. Journal of Virology, February 2014 To identify novel stimulators of the innate immune system, we constructed a panel of eight HEK293-cells lines, double-positive for human Toll-like...

Purification of Vero Cell Derived Live Replication Deficient Influenza A and B Virus by Ion Exchange Monolith Chromatography

M. Banjac, E. Roethl, F. Gelhart, P. Kramberger, B. Lah Jarc, M. Jarc, A. Štrancar, T. Muster, M. Peterka Vaccine 2014 We explored the possibilities for purification of various ΔNS1...

Separation of Human Immunoglobulin G Subclasses on a Protein a Monolith Column

P. Leblebici, M. E. Leblebici, F. Ferreira-da-Silva, A. E.Rodrigues, L. S. Pais Journal of Chromatography B, 962 (2014) 89-93 Monolithic columns have attracted significant attention for the purification of large...

Sample Displacement Chromatography of Plasmid DNA Isoforms

Urh Černigoj, Urška Martinuč, Sara Cardoso, Rok Sekirnik, Nika Lendero Krajnc, Aleš Štrancar Journal of Chromatography A, 1414 Sample displacement chromatography (SDC) is a chromatographic technique that utilises different rela-tive...

Purification of Recombinant Virus-Like Particles of Porcine Circovirustype 2 Capsid Protein Using Ion-Exchange Monolith Chromatography

M. Zaveckas, S. Snipaitis, H. Pesliakas, J. Nainys, A. Gedvilaite Journal of Chromatography B, 991 (2015) 21–28 Diseases associated with porcine circovirus type 2 (PCV2) infection are having a severe...

A New Application of Monolithic Supports: The Separation of Viruses From One Another

J. Ruscic, I. Gutiérrez-Aguirre, M. Tusek Znidaric, S. Kolundzija, A. Slana, M. Barut, M. Ravnikar, M. Krajacic Journal of Chromatography A, 1388 (2015) 69–78 The emergence of next-generation "deep" sequencing...

Optimization of Supercoiled HPV-16 E6/E7 Plasmid DNA Purification With Arginine Monolith Using Design of Experiments

A.M. Almeida, J.A. Queiroz, F. Sousa, A. Sousa Journal of Chromatography B, 978–979 (2015) 145–150 The progress of DNA vaccines is dependent on the development of suitable chromatographic procedures to...

Purification of HIV-1 Gag Virus-Like Particles and Separation of Other Extracellular Particles

P. Stepperta, D. Burgstallera, M. Klausbergera, E. Bergerb, P.P. Aguilara, T.A. Schneiderb, P. Krambergerc, A. Toverd,  K. Nöbauere, E. Razzazi-Fazelie, A. Jungbauer Journal of Chromatography A, 1455 (2016) Enveloped virus-like...

Depletion of Human Serum Albumin in Embryo Culture Media for in Vitro Fertilization Using Monolithic Columns With Immobilized Antibodies

Tarasova, I. A., Lobas, A. A., Černigoj, U., Solovyeva, E. M., Mahlberg, B., Ivanov, M. V., Panić-Janković, T., Nagy, Z., Pridatchenko, M. L., Pungor, A., Nemec, B., Vidič, U., Gašperšič,...

Purification of Adenoviral Vector Serotype 5 for Gene Therapy Against Alcoholism Using Anion Exchange Chromatography

Alicia T Lucero, Sergio A Mercado, Anamaría C Sánchez,Carolina A Contador, Barbara A Andrews and Juan A Asenjo Journal of chemical technology and biotechnology, (2017) BACKGROUND: Gene therapy is a...

Towards Automation in Protein Digestion: Development of a Monolithic Trypsin Immobilized Reactor for Highly Efficient On-Line Digestion and Analysis

Marina Naldi, Urh Černigoj, Ales Štrancar, Manuela Bartolini Talanta, Volume 167 Reducing experimental variability, limiting contamination and increasing automation are essential goals in the development of reliable analytical platforms for mass...

A Novel Toolbox for E. Coli Lysis Monitoring

V.Rajamanickam, D.Wurm, C.Slouka, C.Herwig, O.Spadiut Anal Bioanal Chem (2016) The bacterium Escherichia coli is a well-studied recombinant host organism with a plethora of applications in biotechnology. Highly valuable biopharmaceuticals, such...

Active Yeast Ribosome Preparation Using Monolithic Anion Exchange Chromatography

Antonio M. Munoz, Paul Yourik, Vaishnavi Rajagopal, Jagpreet S. Nanda, Jon R. Lorsch, Sarah E. Walker RNA Biology, 2017, VOL. 14, NO. 2, 188–196 In vitro studies of translation provide...

The Development of a Monolith-Based Purification Process for Orthopoxvirus Vaccinia Virus Lister Strain

David Vincent, Petra Kramberger, Rosana Hudej, Aleš Štrancar, Yaohe Wang,Yuhong Zhou, Ajoy Velayudhan Journal of Chromatography A The purification of large viruses remains an important field of research and development....

Purification of Cell Culture-Derived Influenza A Virus via Continuous Anion Exchange Chromatography on Monoliths

Laura M. Fischer, Michael W. Wolff, Udo Reichl Vaccine, Volume 36, Issue 22 The continuously increasing demand for potent and safe vaccines and the intensifying economic pressure on health care...

Comparison of CIM C4-HLD Monolithic Column With Sartobind Phenyl Membrane Column for pIDKE2 Purification

Miladys Limonta, Lourdes Zumalacarregui, Urska Vidic, Nika Lendero Krajnc Chinese Journal of Chromatography, Vol. 35, No. 10 The main component of the Center for Genetic Engineering and Biotechnology (CIGB) candidate...

Intensification of Influenza Virus Purification: From Clarified Harvest to Formulated Product in a Single Shift

M. Tajnik Sbaizero, M. Wolschek, M. Reiter, T. Muster, Pete Gagnon and Aleš Štrancar BioProcess International, 15 October 2018 Abstract: Influenza is a global respiratory disease with an estimated mortality...

Emerging Tools for Exosome Purification and In-Process Monitoring

Katja Vrabec, Tjasa Lojpur, and Pete Gagnon BPI eBook This discussion introduces new analytical approaches that enable in-line chromatographic detection of exosomes. One approach can discriminate extracellular vesicles from nonvesicle...

Purification of Rabies Virus Produced in Vero Cells Grown in Serum Free Medium

K. Trabelsi, M. Ben Zakour, H. Kallel Vaccine (2019) Rabies is a viral zoonosis caused by negative-stranded RNA viruses of the Lyssavirus genus. It can affect all mammals including humans....

Analytical Strategies for Quantification of Adeno-Associated Virus (AAV) Empty Capsids to Support Process Development

Dr. Xiaotong Fu, Dr. Wei-Chiang  Chen, C. Argento, R. Dickerson, P. Clarner, V. Bhatt, G. Bou-Assaf, Dr. M. Bakhshayeshi, Dr. Xiaohui Lu, Dr. S. Bergelson, Dr. J. Pieracci Human Gene...

Rapid Affinity Chromatographic Isolation Method for LDL in Human Plasma by Immobilized Chondroitin-6-Sulfate and Anti-apoB-100 Antibody Monolithic Disks in Tandem

Thanaporn Liangsupree, Evgen Multia, Jari Metso, Matti Jauhiainen, Patrik Forssén, Torgny Fornstedt, Katariina Öörni, Aleš Podgornik & Marja-Liisa Riekkola Scientific Reports, volume 9, August 2019 Low-density lipoprotein (LDL) is considered the major risk factor for the development of atherosclerotic...

Fast Isolation of Highly Specific Population of Platelet-Derived Extracellular Vesicles From Blood Plasma by Affinity Monolithic Column, Immobilized With Anti-human CD61 Antibody

Evgen Multia, Crystal Jing Ying Tear, Mari Palviainen, Pia Siljander, Marja-Liisa Riekkola Analytica Chimica Acta (2019), Volume 1091 A new, fast and selective immunoaffinity chromatographic method including a methacrylate-based convective...

Simian Adenovirus Vector Production for Early-Phase Clinical Trials: A Simple Method Applicable to Multiple Serotypes and Using Entirely Disposable Product-Contact Components

Sofiya Fedosyuk, Thomas Merritt, Marco Polo Peralta-Alvarez, Susan J. Morris, Ada Lam, Nicolas Laroudie, Anilkumar Kangokar, Daniel Wright, George M. Warimwe, Phillip Angell-Manning, Adam J. Ritchie, Sarah C. Gilbert, Alex...

Monolithic Chromatography on Conjoint Liquid Chromatography Columns for Speciation of Platinum-Based Chemotherapeutics in Serum of Cancer Patients

Katarina Marković, Radmila Milačič, Janja Vidmar, Stefan Marković, Katja Uršič, Martina Nikšić Žakeljc, Maja Cemazar, Gregor Sersa, Mojca Unk, Janez Ščančar Journal of Trace Elements in Medicine and Biology, Volume...

Developing an Anion Exchange Chromatography Assay for Determining Empty and Full Capsid Contents in AAV6.2

Wang Chunlei, Mulagapati Sri Hari Raju, Chen Zhongying, Du Jing, Zhao Xiaohui, Xi Guoling, Chen Liyan, Linke Thomas, Gao Cuihua, Schmelzer Albert, Liu Dengfeng Molecular Therapy  Methods & Clinical Development,...

Development and Characterization of PEGylated Chromatographic Monoliths as a Novel Platform for the Separation of PEGylated RNase a Isomers

Calef Sánchez-Trasviña, Marco Rito-Palomares, and José González-Valdez Advances in Polymer Technology, Volume 2019, December 12 2019, 10 pages Abstract: PEGylated or polyethylene glycol-modified proteins have been used as therapeutic agents...

The Removal of Endo- And Enterotoxins From Bacteriophage Preparations

Hietala V, Horsma-Heikkinen J, Carron A, Skurnik M, Kiljunen S. Frontiers in microbiology vol. 10 1674. 23 Jul. 2019 Abstract: The production of phages for therapeutic purposes demands fast, efficient...

Setting a Cornerstone for Platform Purification of Exosomes

Pete Gagnon, Katja Vrabec, Tjaša Lojpur, and Aleš Štrancar BioProcess International, 18 (4) April 2020 Abstract: Exosomes are a subject of rapidly growing therapeutic interest in the biopharmaceutical industry for...

Two New Capture Options for Improved Purification of Large mRNA

P. Gagnon, B. Goričar, Š. Peršič, U. Černigoj, A. Štrancar Cell & Gene Therapy Insights 2020; 6(7), 1035–1046 Abstract: One of the barriers to development of industrial purification platforms for...

Book: Challenges in Industrial Process Development of Exosome-Based Therapies: Characterizing and Managing Diversity

Simon Staubach, Pete Gagnon, Katja Vrabec, Tjaša Lojpur, Sebastijan Peljhan, Bernd Giebel and Aleš Štrancar BioProcess International, 2020 Abstract: The traditional classification of extracellular vesicles (EVs) includes three types: exosomes,...

eBook: Viral Vector Purification — A Discussion of Current Challenges and Methods

Maribel Rios, Aleš Štrancar, J. Michael Hatfield and Pete Gagnon BioProcess International, 2020 Abstract: Adenoassociated viral (AAV) vectors have become synonymous with gene therapy delivery. However, because they are produced...

Multiple-Monitor HPLC Assays for Rapid Process Development, In-Process Monitoring, and Validation of AAV Production and Purification

Pete Gagnon, Blaz Goricar, Nina Mencin, Timotej Zvanut, Sebastijan Peljhan, Maja Lescovec and Ales Strancar Pharmaceutics. 2021 Jan 17;13(1):113 Abstract: HPLC is established as a fast convenient analytical technology for...

Streamlining Industrial Purification of Adeno-Associated Virus

Pete Gagnon, Maja Leskovec, Blaz Goricar, and Aleš Štrancar BPI, December 17, 2020 Abstract: With its first licensed therapeutic now marketed worldwide, adeno-associated virus (AAV) has become a preferred vector...

Multiple-Parameter Profiling of Density Gradient Ultracentrifugation for Characterization of Empty and Full Capsid Distribution in AAV Preparations

Sebastijan Peljhan, Maja Štokelj, Sara Drmota Prebil, Pete Gagnon and Aleš Štrancar Cell & Gene Therapy Insights, March 2021 Abstract: Ultracentrifugation (UC) is a well-known technique for fractionating adeno-associated virus...

Modern Isolation and Separation Techniques for Extracellular Vesicles

Thanaporn Liangsupree, Evgen Multia, Marja-Liisa Riekkola Journal of Chromatography A, Volume 1636, 2021 Abstract: Extracellular vesicles (EVs) are heterogenous membrane-bound vesicles released from various origins. EVs play a crucial role...

Purification of Guanine-Quadruplex Using Monolithic Stationary Phase Under Ion-Exchange Conditions

Artaches A. Kazarian, Wesley Barnhart, Iain D.G. Campuzano, Jeremy Cabrera, Theodore Fitch, Jason Long, Kelvin Sham, Bin Wu, Justin K. Murray Journal of Chromatography A,Volume 1634, 2020 Abstract: The current...

Removal of Empty Capsids from Adeno-Associated Virus Preparations by Multimodal Metal Affinity Chromatography

Pete Gagnon, Maja Leskovec, Sara Drmota Prebil, Rok Žigon, Maja Štokelj, Andrej Raspor, Sebastijan Peljhan, Ales Štrancar Journal of Chromatography A, 2021 Abstract: Separation of empty and full adeno-associated virus...

Eliminating the Analytical Bottleneck in Production and Purification of mRNA

Tomas Kostelec, Rok Sekirnik, Anže Martinčič Celjar, Kristina Šprinzar Nemec, Andreja Gramc Livk, Pete Gagnon, Aleš Štrancar BioProcess International, June 2021 Abstract: COVID-19 has focused a spotlight on the ability...

Adenoviral Vector COVID-19 Vaccines: Process and Cost Analysis

Rafael G. Ferreira, Neal F. Gordon, Rick Stock, Demetri Petrides Processes 2021, 9(8), 1430 Abstract: The COVID-19 pandemic has motivated the rapid development of numerous vaccines that have proven effective...

Guanidine Improves DEAE Anion Exchange-Based Analytical Separation of Plasmid DNA

Urh Černigoj, Jana Vidič, Ana Ferjančič, Urša Sinur, Klemen Božič, Nina Mencin, Anže Martinčič Celjar, Pete Gagnon, Aleš Štrancar Electrophoresis, September 2021 Abstract: Elution of strong and weak anion exchangers...

Separation of Empty and Full Adeno-Associated Virus Capsids From a Weak Anion Exchanger by Elution With an Ascending PH Gradient at Low Ionic Strength

Pete Gagnon, Blaž Goričar, Sara Drmota Prebil, Hana Jug, Maja Leskovec, Aleš Štrancar BioProcess J, 2021; 20 Abstract: Separation of empty and full AAV8 capsids was achieved during their elution...

Chromatographic Purification With CIMmultus Oligo dT Increases mRNA Stability

Matevž Korenč, Nina Mencin, Jasmina Puc, Janja Skok, Kristina Šprinzar Nemec, Anže Martinčič Celjar, Pete Gagnon, Aleš Štrancar, Rok Sekirnik Cell & Gene Therapy Insights 2021; 7(9), 1207–1216 Abstract: One...

Chromatography in mRNA Production Workflows

Rok Sekirnik and Tomas Kostelec BioProcess International's special report, December 2021 Abstract: Rapid response to global pandemics requires the manufacture of billions of vaccine doses within months. This short timeline...

Increasing Dynamic Binding Capacity of Oligo(dT) for mRNA Purification: Experimental Results Using CIM 96-Well Plates

Nina Mencin, Andreja Krušic, Jure Ličen, Sebastijan Peljhan, Jana Vidič, Urh Černigoj, Tomas Kostelec, Aleš Štrancar and Rok Sekirnik BioProcess International's Special Report, June 2022 Abstract: Messenger RNA (mRNA) emerged...

Speciation of Copper in Human Serum Using Conjoint Liquid Chromatography on Short-Bed Monolithic Disks With UV and Post Column ID-ICPMS Detection

Katarina Markovič, Maja Cemazar, Gregor Sersa, Radmila Milačič and Janez Sčančar Journal of Analytical Atomic Spectrometry Abstract: Ceruloplasmin (Cp) is the major copper-carrying (Cu) protein in human plasma. Due to copper's important physiological...

Comprehensive Studies on Building A Scalable Downstream Process for mRNAs To Enable mRNA Therapeutics

Tingting Cui, Kareem Fakhfakh, Hannah Turney, Gülin Güler-Gane, Aleksandra Toloczko, Martyn Hulley, Richard Turner American Institute of Chemical Engineers, September 2022 Abstract: In recent years, mRNA-based therapeutics have been a...

High-Selectivity Biochromatography mRNA Analytics

Ana Ferjančič Budihna, Nejc Pavlin, Anže Martinčič Celjar, Andreja Gramc Livk and Aleš Štrancar BioProcess International eBook, September 14, 2022 Abstract: Robust and precise chromatographic analytical methods are key for...

Gram-Scale mRNA Production Using a 250-mL Single-Use Bioreactor

Janja Skok, Polona Megušar, Tina Vodopivec, Domen Pregeljc, Nina Mencin, Matevž Korenč, Andreja Krušič, Anže Martinčič Celjar, Nejc Pavlin, Jana Krušič, Matthias Mueller, Kevin McHugh, Aleš Štrancar, and Rok Sekirnik...

Development and Scale-up of Oligo-dT Monolithic Chromatographic Column for mRNA Capture Through Understanding of Base-Pairing Interactions

Nina Mencin, Dona Štepec, Alja Margon, Jana Vidič, Darko Dolenc, Tina Simčič, Sara Rotar, Rok Sekirnik, Aleš Štrancar, Urh Černigoj Separation and Purification Technology, Volume 304, 1 January 2023 Abstract:...

Roadmap to Success in AAV Purification. In-Process Control, High Throughput & Novel Column Modalities as Necessary Means for Control Over Scalable AAV Process

Rok Žigon, Mojca Tajnik Sbaizero, Ivana Petrović Koshmak, Veronika Fujs, Maja Leskovec & Aleš Štrancar Cell & Gene Therapy Insights 2022; 8(10), 1315–1328 Abstract: Manufacture and purification of recombinant adeno-associated...

CIM Monolithic Chromatography as a Useful Tool for Endotoxin Reduction and Purification of Bacteriophage Particles Supported with PAT Analytics

Lucija Rebula, Andrej Raspor, Mojca Bavčar, Aleš Štrancar and Maja Leskovec Journal of Chromatography B, Volume 1217, 15 February 2023 Abstract: Bacteriophages represent immense potential as therapeutic agents. Many of...

Production and Purification of Newcastle Disease Virus: A High-Yield Platform Process Based on a Novel Avian Cell Line and Monolith Chromatography

Hana Jug, Natalija Hosta, Mojca Tajnik Sbaizero, Aleš Štrancar, Daniela Brodesser, Bianca Tisch, Theresa Heger, Markus Wolschek, Joachim Seipelt and Manfred Reiter BioProcess International, 9 February 2023 Abstract: Newcastle disease...

Comparative Analysis of Transferrin and IgG N-Glycosylation in Two Human Populations

Irena Trbojević-Akmačić, Frano Vučković,Tea Pribić, Marija Vilaj, Urh Černigoj, Jana Vidič, Jelena Šimunović, Agnieszka Kępka, Ivana Kolčić, Lucija Klarić, Mislav Novokmet, Maja Pučić-Baković, Erdmann Rapp, Aleš Štrancar, Ozren Polašek, James...

Effect of Plasmid DNA Isoforms on Preparative Anion Exchange Chromatography

Špela Kralj, Špela Meta Kodermac, Ines Bergoč, Tomas Kostelec, Aleš Podgornik, Aleš Štrancar, Urh Černigoj Electrophoresis. 2023; 1– 13 Abstract: Increased need for plasmid DNA (pDNA) with sizes above 10...

Purification of a Recombinant Oncolytic Virus From Clarified Cell Culture Media by Anion Exchange Monolith Chromatography

Troy Rogerson,  Guoling Xi,  Amanda Ampey,  Jon Borman,  Sally Jaroudi,  Dan Pappas,  Thomas Linke Electrophoresis. 2023; 1– 11. Abstract: The use of viral vectors for vaccine, gene therapy, and oncolytic...

Insights Into Product and Process Related Challenges of Lentiviral Vector Bioprocessing

Christopher Perry, Noor Mujahid, Yasu Takeuchi, Andrea C. M. E. Rayat Biotechnology and Bioengineering, 2023, 1–16 Abstract: Lentiviral vectors (LVs) are used in advanced therapies to transduce recipient cells for long term gene...

Preferential Exclusion Chromatography as a Capture Step for Extracellular AAV Harvest From Adherent and Suspension Productions

Maja Leskovec, Andrej Raspor, Veronika Fujs, Andrej Mihevc, Aleš Štrancar Electrophoresis. 2023; 1–9 Abstract: Preferential exclusion chromatography (PXC) sometimes described as hydrophobic interaction chromatography is a well-known, but not widely used...

Optimization of rAAV Capture Step Purification Using SO3 Monolith Chromatography

Kaja Bažec, Mirjam Krašna, Andrej Mihevc, Maja Leskovec, Aleš Štrancar, Mojca Tajnik Sbaizero Electrophoresis. 2023; 1–10 Abstract: Adeno-associated virus (AAV) vectors are crucial tools for gene therapy applications. As AAVs...

Pathbreaking Method Leads to Optimised mRNA Production

Rok Sekirnik Research Outreach, 2023 Abstract: The COVID-19 pandemic placed mRNA at the centre of biopharmaceutical research, as mRNA is now being developed for cancer therapy, protein replacement therapy, and...

High Recovery Chromatographic Purification of mRNA at Room Temperature and Neutral pH

Miklavčič, Rok, Polona Megušar, Špela Meta Kodermac, Blaž Bakalar, Darko Dolenc, Rok Sekirnik, Aleš Štrancar, and Urh Černigoj International Journal of Molecular Sciences 24, no. 18: 14267 Abstract: Messenger RNA (mRNA)...

Purification of Linearized Template Plasmid DNA Decreases Double-Stranded RNA Formation During IVT Reaction

Juan Martínez, Verónica Lampaya, Ana Larraga, Héctor Magallón, and Diego Casabona Frontiers in Molecular Biosciences, volume 10, 2023 Abstract: After the COVID-19 pandemic, messenger RNA (mRNA) has revolutionized traditional vaccine manufacturing. With the increasing...

Scalable Multimodal Weak Anion Exchange Chromatographic Purification for Stable mRNA Drug Substance

Polona Megušar, Rok Miklavčič, Matevž Korenč, Jure Ličen, Tina Vodopivec, Urh Černigoj, Aleš Štrancar, and Rok Sekirnik Electrophoresis. 2023; 1–11  Abstract: Messenger RNA (mRNA) has emerged as a modality with immense therapeutic potential. Recent innovations in production process...

mRNA Fragmentation and Quality Assessment Using Ion Pair Reverse-Phase Analytics

Ana Ferjančič Budihna, Anže Martinčič Celjar, Sergeja Lebar, Andreja Gramc Livk and Aleš Štrancar Cell & Gene Therapy Insights 2023; 9(9), 1231–1247 | DOI: 10.18609/cgti.2023.161 Abstract: Rapid advancement of mRNA technology, as...

Analytical and Preparative Chromatography in mRNA Production

Rok Sekirnik, Head Process Development mRNA | pDNA, Sartorius BIA Separations, d.o.o. mRNA Production and Synthesis, InformaConnect eBook, November 2023 Abstract: The use of mRNA vaccines in the fight against...

Bridging Upstream and Downstream for Improved Adenovirus 5 Bioprocess

Ivana Petrović Koshmak, Hana Jug, Katja Vrabec, Ana Mavri, Valentina Novak, Petra Dekleva, Veronika Fujs, Maja Leskovec and Aleš Štrancar Electrophoresis 2023; 1–11 Abstract: Adenoviruses are well-known viral vectors that have been previously used in gene therapy...

Selective Hydrophobic Interaction Chromatography for High Purity of Supercoiled DNA Plasmids

Klemen Božič, Ajda Sedlar, Špela Kralj, Urh Černigoj, Aleš Štrancar, Rok Sekirnik Biotechnology and Bioengineering, 2024, 1–11 Abstract: High purity of plasmid DNA (pDNA), particularly in supercoiled isoform (SC), is...

Determination of Linearized pDNA Template in mRNA Production Process Using HPLC

Marta Leban, Tina Vodopivec Seravalli, Martina Hauer, Ernst Böhm, Nina Mencin, Sandra Potušek, Andrej Thompson, Jurij Trontelj, Aleš Štrancar & Rok Sekirnik Analytical and Bioanalytical Chemistry, March 2024 Abstract: The...

Grafting Chromatographic Monoliths With Charged Linear Polymers for Highly Productive and Selective Protein or Plasmid DNA Purification

Meta Špela Kodermac, Sara Rotar, Darko Dolenc, Klemen Božič, Aleš Štrancar and Urh Černigoj Separation and Purification Technology, vol. 353, Part A. Abstract: Increased requirements for plasmid DNA (pDNA) in...

Chromatographic Separation of Full and Empty AAV8 Capsids

Adeno-associated virus (AAV) vectors of various serotypes are considered to have high potential for gene therapy applications. Currently, manufacturing of AAV vectors faces the challenge of co-production of incompletely formed...

Chromatographic Performance of Novel Polymetacrylate-Based Ion Exchanging Monoliths

Productivity of the downstream bioprocessing depends among others on the efficiency of chromatographic step. One of the crucial chromatographic parameters is dynamic binding capacity (DBC) for certain biomolecule. DBC could...

Optimizing a Separation of IgG Charge Variants Using Weak Cation-Exchanging Analytical Monolithic Column

The upstream and downstream monoclonal antibody (mAb) bioprocessing makes them susceptible to physical and chemical modifications. In the biotechnological production process of mAbs, structural variations may arise due to some...

Optimization of pDNA Downstream Bioprocessing Using Hydrophobic Monoliths in Sample Displacement Mode

Since plasmid DNA (pDNA) as a pharmaceutical product has stringent requirements of purity and efficacy, one or more chromatographic steps are often used in the downstream processing train. High ligand...

Large Volume CIM Chromatographic Monoliths – Scalability and Uniformity

To ensure the desired chromatographic characteristics of the CIM® monolithic column at large scales, monolith microstructure morphology, pore size distribution, porosity and surface ligand density should be uniform. To demonstrate...

Immunoaffinity Columns | Reproducible and Reliable Tool for Analytics and Purification

There are many cases, where a single protein needs to be purified from a complex sample. Such proteins manifest themselves as impurities, which can affect further analysis, either by causing...

Overcoming the Limitations of Large Scale Polymerization

Methacrylate monoliths (CIM monolithic columns) allow for very fast and efficient separations and exhibit very high binding capacities for extremely large bio-particles due to their large inner channel diameters and...

Preparation of Immunoaffinity Columns for Purification and Analytics of MULT-1 and RAE-1

Immunoaffinity columns using antibodies as ligands against mammalian membrane proteins could be used for different applications in protein expression control and, if a standard available, for concentration determination. Additionally these...

High-Speed Quantification of Immunoglobulin G – CIMac r-Protein A Analytical Column

CIMac™ r-Protein A Analytical Column is short bed, high performance monolithic column . Primarily is intended for fast, efficient, and reproducible qualitative and quantitative analyses of Immunoglobulin G (IgG). It...

Testing Different Activation Chemistries for IgG Immobilization Onto a Monolithic Support

Interactions between antibodies and their antigens are highly selective and therefore immensely popular for affinity chromatography. Consequently, numerous antibody immobilizations were performed on monolithic supports via different activation chemistries in...

Quantitative HPLC Determination of IgM in Cell Supernatant on CIM OH Column

Monolithic ion exchange CIM (Convective Interaction Media) columns have been proven in quantitative analysis of different immunoglobulins such as IgM and IgG from human plasma or cell supernatants. The separation...

Phosphopeptide Enrichment on a Monolithic Column Containing Superficially Immobilized Nano TiO2

Enrichment of phosphopeptides prior to LC-MS analysis is a crucial sample preparation step because of their low stoichiometry in biological sample, longer retention on reversed phase columns, and lower ionization...

Development of Methacrylate Monolithic Columns for Depletion of Human Serum Albumin (HSA)

Biological samples often consist of a main component, such as albumin in serum, and many other constituents, present in smaller quantities, but nevertheless of high importance in biological systems. When...

Development of a Separation Method for Exosomes by Means of Large Pore Monolithic Columns

Exosomes are nano-sized vesicles that are released by many different cell types. They are involved in the transport of a wide range of signalling molecules, including mRNA, microRNA and proteins....

Characterization of Chromatographic Monolithic Columns With Different Hydrophobicity

Surface hydrophobicity/hydrophilicity of chromatographic stationary phases is one of the important characteristics that influence the chromatographic column performance. On the one hand, the surface should be highly hydrophilic to avoid...

Analytical Method for Plasmid Isoform Separation Using Histamine Modified Monolithic Columns

One of the major requirements for pharmaceutical-grade pDNA is its high homogeneity, being mostly in supercoiled (sc) isoform. Chromatographic separation of sc pDNA from open coiled (oc) or linear isoform...

Introduction of PAT to Improve the Efficiency and Robustness of Vaccine Development and Manufacturing

Challenges in monitoring the quality of vaccine production • Process Analytical Technology (PAT) ensures process reproducibility in bioprocessing • A mechanism to design, analyze and control pharmaceutical manufacturing processes through...

Purification of Staphylococcus Aureus Bacteriophages VDX-10 Using CIM Monolithic Columns

In recent years bacteriophages were identified as a useful potential tool for different applications such as alternative to antibiotics, detection of pathogenic bacteria, delivery vehicles for protein and DNA vaccines...

Using Fingerprint HPLC Method to Develop and Control IgG (IVIG) From Cohn (I+II+III) Paste Production Process

The demand for human immunoglobulin is invariably increasing on an annual basis. To satisfy demands, different manufacturing processes are used to isolate immunoglobulins from human plasma. A quest for alternative...

CIMac Analytical Columns for In-Process Control of Adenoviruses

Determining the concentration of viruses is a crucial step in any production process. The most commonly used methods for virus quantification are either based on the infectivity of the virus...

Development of TiO2-Coated Monolithic Columns for Phosphopeptides Enrichment

Phosphoproteomics is a branch of proteomics that focuses on deriving a comprehensive view of the extent & dynamics of protein phosphorylation by way of identifying & characterizing proteins that contain...

PATfix® Analytical Method for Orf Virus Sample Characterization

In recent years, the Orf virus (ORFV) has become a promising tool for protective recombinant vaccines and oncolytic therapy. Regardless of the high potential for use and the broad range...

Elevate Your AAV Chromatography With Our Latest Innovations and Services

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Insights From Our Latest Research: Enhancing AAV, Lentivirus, And mRNA Processes

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Reverse-Phase Chromatography Removes Double-Stranded RNA, Fragments and Residual Template to Decrease Immunogenicity and Increase Cell Potency of mRNA and saRNA

We present a comprehensive study of ion-pair reverse-phase (IP-RP) chromatography for mRNA polishing, demonstrating its ability to remove double-stranded RNA (dsRNA), RNA fragments and residual DNA template. We developed a...

PATfix System Software Presentation

Analytical chromatography is rapidly gaining supremacy as the leading process development & optimization method for novel gene therapies, combining detection accuracy with the separation ability of CIMac™ columns.Making sure your...

Newsletter Archive

2024 Sartorius BIA Separations | Newsletter May Get Ready for MSS2024 Sartorius BIA Separations | Newsletter May Fast In-Process Analytics to Enable Robust mRNA Manufacturing Poster: mRNA |...

A PATfix® Analytical Method for Adenovirus Sample Characterization in Upstream Process Development

Adenovirus is well-know gene therapy tool that gained attention as a promising vaccine delivery vehicle, specially during Covid-19 pandemics, where it was used to deliver sequence for protein S (S)....

Optimization of Upstream Extracellular Vesicle Processes Using PATfix® Analytical Tools

Extracellular vesicles (EV) are lipid bound products secreted by cells. Among them, exosomes have great potential for clinical applications. Animal and human-derived components used in cell culture, such as fetal...

Application of PATfix® Valve Switch Analytics in Media Screening for AAV8 Production

Recombinant adeno-associated viral (rAAV) vectors are the leading gene delivery tool for treatment of a variety of diseases. While several rAAV mediated therapies have been approved so far, and many...

2018-2020 BIA Separations' Newsletter Archive

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Enhanced AAV Production With CIMmultus® SO3 Capture Step

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2021 BIA Separations' Newsletter Archive

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2022 Sartorius BIA Separations' Newsletter Archive

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2023 Sartorius BIA Separations' Newsletter Archive

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Utilizing CIMmultus® OH for Efficient Purification of MSC EVs

Mesenchymal stem cell (MSC)-derived extracellular vesicles (EVs) have promising therapeutic potential in diverse applications, such as tissue regeneration and immunomodulation. On the pathway to the clinic, there is a substantial...

Immobilization Procedures for Aldehyde Monolithic Columns

This procedure applies to CIMac Analytical Columns (0.1 mL), CIMmic, and CIMmultus Columns (1 mL and larger) of aldehyde (ALD) activation chemistry.

Immobilization Procedures for CDI Monolithic Columns

This procedure applies to CIMac Analytical Columns (0.1 mL), CIMmic, and CIMmultus Columns (1 mL and larger) of carboxy imidazole (CDI) activation chemistry.

Immobilization Procedures for Epoxy Monolithic Columns

This procedure applies to CIMmultus Columns (1 mL and larger) of Epoxy (XY) activation chemistry.

Immobilization Procedures for HDZ Monolithic Columns

This procedure applies to CIMac Analytical Columns (0.1 mL), CIMmic, and CIMmultus Columns (1 mL and larger) of hydrazide (HDZ) activation chemistry.

Optimization of mRNA Production and Purification | Characterization And Controlling of Post Transcriptional Polyadenylation

While mRNA therapeutics developed in recent years show tremendous potential, there are still technical obstacles to overcome, two of the most significant being mRNA’s intrinsic instability and its immunogenicity. In...

Fast In-Process Analytics to Enable Robust mRNA Manufacturing

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA SeparationsAbstract: Typical mRNA production process involves four key steps: 1) plasmid DNA (pDNA) expression in E.coli, linearization and pDNA purification, 2) in-vitro transcription...

From Process Development to Manufacturing: How to Successfully Optimize and Scale up the AAV Enrichment Step on Novel CIMmultus QA HR Line

Watch the presentation to learn about: Chromatographic purification of AAV Development of the enrichment step Improving resolution and reproducibility with the CIMmultus HR line Successful scale up Speaker: Rok...

Optimization of LC System for Analytical Work

The main goal of this document is to advise how to shorten the flow path of (HP)LC system so that it can be used with a CIMac column.

Sample Pre-treatment and Troubleshooting Increased Pressure

It is a general recommendation to carefully consider pre-treatment steps that your sample undergoes before column purification. For viruses, VLPs, phages and other large biomolecules, pre-treatment is essential to prevent...

Mobile Phase Compatibility of CIM Monoliths

This document discusses the compatibility of monoliths with different aqueous solutions and organic solvents.

Connectors and Adapters for CIM Columns

This document lists the various types of connectors and adapters that are compatible with CIM monolithic columns.

CIM QA Monolithic Column for Enrichment of Virus Particles From Clinical Samples Prior to Next-Generation Sequencing (NGS)

Orthoreoviruses are dsRNA, non-enveloped viruses that can cause severe enteric and respiratory infections in humans and other animals. It is speculated that these viruses might be an important zoonotic pathogen....

HPLC Fingerprint Characterization as a Process Analytical Technology in the Processing of Cohn I+II+III Derived IgG

The demand for human normal immunoglobulin is invariably increasing on an annual basis. To satisfy increasing demands, different manufacturing processes are used to isolate immunoglobulins from human plasma. A quest...

Recovery of pDIKE2 Plasmid for Hepatitis C Vaccine Using CIMmultus C4 HLD Advanced Composite Column cGMP

DNA immunization can potentially induce both, humoral and cellular immune responses, and thus comprises an attractive approach for the development of an effective vaccine against HCV. The pIDKE2 plasmid is...

Chromatographic Separation of Full and Empty AAV8 Capsids

Adeno-associated virus (AAV) vectors of various serotypes are considered to have high potential for gene therapy applications. Currently, manufacturing of AAV vectors faces the challenge of co-production of incompletely formed...

Chromatographic Separation of Full and Empty Adeno-Associated Virus (AAV) Particles on CIM Monoliths

Adeno-Associated Virus (AAV)-based vectors of various serotypes are considered to have high potential in human gene therapy and genetic vaccination applications. During manufacturing of AAV vectors undesired, incomplete particles are...

Comparison of Fibrinogen Quantification by CIMac Immunoaffinity Chromatography and Clotting Activity Measurement

In diagnostic applications, fibrinogen is measured with clotting activity assay variations, together with other blood clotting factors. In research and preparative applications, larger quantities of anti-coagulants, such as EDTA and...

The Power of Immunoaffinity Chromatography on CIMac Platform | Studying Glycosylation Profile of Fibrinogen in Human Plasma

The CIMac antibody immobilization platform enables an elegant immobilization of antibodies, which can be used as immunoaffinity adsorbents in specific diagnostic applications. Immobilization of antibodies to solid chromatographic supports is...

A Fast and Reproducible HPLC Method for Quantification of Adenoviruses

Determining the concentration of viruses is a crucial step in any production process. The most commonly used methods for virus quantification are either based on the infectivity of the virus...

Separation of PEGylated Ribonuclease A Using a CIM C4 A Disk (Butyl)

PEGylation involves the formation of a stable covalent bond between activated poly (ethylene glycol) polymers and polypeptidic drugs and molecules. This process causes a change in protein hydrophobicity and results...

Versatility of CIM Monoliths for Covalent Immobilization of Antibodies

The CIMac antibody immobilization platform enables an elegant immobilization of antibodies, which can be used as immunosorbents in specific diagnostic applications as well as in downstream processes. In this work...

CIM @tf-0.2 Monolithic 96-Well Plate for Immunoaffinity Isolation of Transferrin From Human Plasma

Transferrin (Tf) is a glycoprotein that transports iron to cells and has two N-glycosylation sites in humans – at asparagine 432 and asparagine 630. Carbohydrate-deficient Tf, which lacks one or...

CIMac COOH Monolith for Separation of Monoclonal Antibodies Charge Variants in pH Gradient

Monoclonal antibody (mAb) charge variants have gained considerable attention in the biotechnology industry, due to their potential influence on stability and biological activity of the active pharmaceutical. Cation-exchange chromatography (CEX)...

High-Speed Quantification of Immunoglobulin G CIMac r-Protein A Analytical Column

CIMac r-Protein A Analytical Column is a short bed, high performance monolithic column. It is intended for fast, efficient, and reproducible qualitative and quantitative analyses of Immunoglobulin G (IgG) and...

Comparison of Hydrophobic Monolithic Supports for Sample Displacement Chromatography of Plasmid DNA

Sample displacement chromatography exploits the different relative binding affinities of components in a sample mixture to achieve accummulation of a desired substance on the column before elution. In pharmaceutical applications,...

A Method for Concentration and Purification of Human Coronavirus HCoV-OC43 Using CIM QA Monolithic Columns

Human coronavirus OC43 (HCoV-OC43) is a frequent cause of respiratory tract illness, ranging from common cold to severe disease. The research on coronaviruses and medical application of coronaviral vectors/vaccines requires...

Depletion of Human Serum Albumin in Embryo Culture Media for in Vitro Fertilization Using Immunoaffinity Chromatography

Bottom-up proteomic approach based on tandem mass spectrometry (MS/MS) is a method of choice for identification and quantitation of proteins in the complex biological samples. Followed by quantitative analysis of...

Conjoint Liquid Chromatography on CIM Monoliths in Speciation of Pt-Based Chemotherapeutics in Human Serum

As an alternative to conventional particle-packed columns for liquid chromatography, CIM monolithic supports can be used.  They are extremely permeable and allow very efficient mass transport at low back pressures...

Applicability of CIM Monolithic Chromatography in Nickel Speciation Analysis

The application describes separation of Ni species by assembling four weak CIM DEAE anion-exchange disks into a monolithic column. The concentrations of the Ni species eluted from the column were...

Speciation of Pt in Serum of Cancer Patients on CLC Monolithic Columns With ICP-MS Detection

In speciation analysis of anticancer metallodrugs, size exclusion chromatography (SEC) coupled to inductively coupled plasma mass spectrometer (ICP-MS) is frequently used. The size exclusion coupled ICP-MS is troubled by low...

Preparing Small Affinity Monoliths for Antibody Purification | Reproducibility of Covalent Immobilization of Recombinant Protein a on CIMmic CDI-0.1 Column

CIMmic Monolithic Columns combine the advantages of the CIM stationary phase with a flexible design and the possibility to operate with syringe. Discs containing the stationary phase can be easily...

Optimization of Covalent Immobilization of Recombinant Prokaryotic Lectins on CIMmic Platform

Pre-activated CIMmic Monolithic Columns are used as a basis for preparation of small volume affinity chromatographic columns as well as enzyme reactors. Small bed volume and flexible design makes them...

Oligo dT Immobilization on CIMmic CDI-0.1 Column

Pre-activated CIMmic monolithic columns are cost efficient tools for screening of immobilization conditions and small scale proof-of-concept testing of custom affinity columns and enzymatic reactors. Each column is assembled from...

Depletion of Human Serum Albumin From Plasma Samples by Immunoextraction on Immobilized Immuno-Affinity CIMmic

Polyclonal anti-HSA antibodies were immobilized on CIMmic HDZ (hydrazide chemistry, 100 μL bed volume), following an optimized protocol. This CIMmic α-HSA column was prepared to quantitatively remove human serum albumin...

Scaling up CIM Trypsin Immobilized Enzyme Reactors for Industrial Scale Production of Whey Proteins Hydrolysate

Coupling trypsin directly onto a Convective interaction media (CIM) monolithic chromatographic support makes it possible to reuse the enzyme for multiple process cycles and to automate hydrolysis processes. Sartorius BIA...

CIMac pDNA-0.3 Analytical Column | Optimizing Its Chromatographic Reproducibility

CIMac pDNA-0.3 Analytical Columns (channels 1.4 μm) were introduced by Sartorius BIA Separations d.o.o. in 2010. In the following years they were recognized by the biotechnological and analytical community as...

Influence Of The Flow Rate On The Separation Efficiency Of CIMac SO3 Analytical Column

CIMac SO3 Analytical Column is a strong cation exchanger based on a monolithic support. This material provides many advantages over conventional stationary phases for the separation of biomacromolecules, such as:...

Chemical Stability of CIMac Analytical Columns

The stability of QA, DEAE and SO3 CIMac Analytical Columns was tested according to the CIP (Cleaning In Place) procedures described in the respective Product Specification Sheets (see Table 1)....

Miniaturization of Trypsin Immobilized Enzymatic Reactor for Protein Digestion

Miniaturized immobilized enzymatic reactors can be used for small scale digestion of proteins. There is need for such devices; small scale devices are used either for processing of analytical sample...

Exploring CIMac PrimaS for Analysis of mRNA

CIMac PrimaS is a new member of BIA’s family of high performance chromatography products for analysis and purification of mRNA. Its positive charge gives it some anion exchange behavior but...

PATfix pDNA Analytics for In-Process Control of Linear pDNA Production

Optimized analytical methods are key components of a well-functioning analytical system, while method development usually comes with a time-consuming learning curve and optimization. PATfix pDNA analytics platform, designed for in-process...

PATfix mRNA Analytical Methods for Process Development and Production

Robust and precise chromatographic analytical methods are key for efficient development of mRNA production process. Three different analytical methods, which utilize three different column chemistries, are embedded in a ready-to-use...

PATfix | At-Line Monitoring of Impurities and Critical Quality Attributes in Biopharmaceutical Up- And Downstream Processes Using PATfix Analytical Fingerprinting

Production of high value biological therapeutics usually involves complex manufacturing processes with high process variability. Additionally, development of robust and reliable bioprocesses can be challenging. PAT aims to enhance bioprocess...

Fast Purification and Analysis of Influenza A Virus Using CIMac Monolith Columns

New vaccines against Influenza A are required each year to keep up with the most virulent evolving strains. This highlights a need for predictive analytical tools that can aid purification...

Sample Displacement Chromatography of Plasmid DNA Isoforms

Preparative scale chromatographic separation of open-circular (oc) from supercoiled (sc) plasmid DNA (pDNA) isoforms has been already established on CIM C4 with high ligand density (C4 HLD) monolithic columns with...

HEK293-Derived Adeno Associated Virus (AAV) Purification | Comparison of Small Scale Laboratory Production Towards Industrial Format Using Monoliths

During recombinant adeno associated virus (rAAV) downstream processing, a large amount of host-cell and product related impurities needs to be removed from the product. Successful process on laboratory scale, such...

One-Step Monolith Purification of Oncolytic Influenza Virus Produced in Vero Cells

Chromatography is a useful purification method for large biomolecules and virus manufacturing and it is easily scalable to large production volumes. Convective Interaction Media (CIM) monolithic columns constitute of large...

Chromatographic Monoliths With Hydrazide Modified Surface | New Member of CIM Family

Hydrazide-activated (HDZ) columns were proven to be a product of choice for making the most effective immunoaffinity columns. They take advantage of a special hydrazide linkage that binds antibodies through...

An Industrial Purification Platform for AAV

This poster presents fully scalable non-affinity purification strategy that has been proven to be effective for all AAV serotype tested to date. Cell lysate is directly subjected to column purification...

Purification and Analytics of pDNA Using Hydrophobic Monoliths in Sample Displacement Mode

CIM chromatographic monoliths enable high 1) productivity of pDNA downstream process (DSP) due to high dynamic binding capacity for pDNA in small elution volumes and short chromatographic runs; 2) high...

Estimation of Empty and Full AAV10 Particle Ratio Using the Multi-Angle Light Scattering Detector

Serotype 10 adeno-associated virus (AAVrh_10mCherry) was analysed on the PATfix system with the CIMac AAV full/empty analytical column to estimate the ratio of empty and full AAV particles based on...

Comparison of Fluorescence and Multi-Angle Light Scattering for Rapid Quantitation of Bacteriophage

One of the handicaps of working with bacteriophages is the long duration required to perform plaque assays. Plaque assays also impose questions about accuracy and precision relative to the scale...

Two Step Purification Process for Bacteriophages With CIM Monoliths

Bacteriophages represent immense potential as therapeutic agents. Many of the most compelling applications of bacteriophages involve human therapy, some pertinent to gene therapy, others involving antibiotic replacement. In bacteriophage research...

Exosome Purification With CIMmultus EV-1 Advanced Composite Column

Exosomes fulfill a critical role as communicators among cells, with targeting and message content depending on their surface receptors and payload. This makes them obvious candidates for an extensive range...

Process Monitoring Using Immunofluorescence and Multi Angle Light Scattering | Tracking Extracellular Vesicles on Analytical PATfix Platform

This poster shows how Multi-Angle Light Scattering detector and Fluorescence detector coupled to PATfix analytical system can be used to track extracellular vesicles through purification process. Samples were analyzed by...

Orthogonal Characterization of AAV Samples by Simultaneous Monitoring of Multiple Analytical Parameters During Chromatography

Fast, accurate, and meaningful characterization of cell culture harvests and in process samples is critical for both process development and for documentation of in process control. UV analysis of chromatography...

Fluorescence, Light Scattering and UV Absorbance Detector Calibration Plots of Empty and Full AAV2|8 Capsid Mixtures

AAV vector lots are generally a heterogeneous mixture of empty particles (i e do not contain DNA) and full particles (i.e. contain DNA). Different spectrometric based methods can be used...

Improving Separation of Empty and Full AAV Capsids With a New Multimodal Column Chemistry: CIMac PrimaS (AAV) Beta

Separation of empty and full AAV capsids is important analytically as a means of monitoring the effects of different transfection strategies, cell culture conditions, lysis methods, sample preparation and purification...

Characterization of Empty and Full AAV Capsids in Complex Samples by Anion Exchange HPLC With Multiple Monitors

Bioreactor cell supernatants or post lysis materials entering downstream purification are heterogeneous mixtures of empty, full, and misassembled AAV capsids mixed with host cell proteins, genomic DNA, chromatin complexes, and...

Preparation of Linear Plasmid DNA for in Vitro Transcription Reaction

Linearised pDNA is currently the starting point of In-Vitro-Transcription processes to synthesize mRNA. Large scale purification protocols for manufacturing of pDNA used for Gene Therapy applications typically include two chromatography...

Removal of Host Cell DNA and Other Contaminants From Exosome Preparations

Removal of host cell DNA is essential for all human-injectable biologics. This poster shows a method for achieving low host cell levels in preparations of exosomes. Purified exosome samples were...

Adeno Virus Vector Manufacturing Platform Using CIMmultus QA Column to Produce Safer Vaccines Cheaper

Adenovirus has after two decades gained new consideration and is now used as a COVID-19 vaccine delivery vehicle. To reduce side effects of the vaccine it’s purity is of utmost...

Separation of Empty and Full AAV Capsids by Multimodal Metal Affinity Chromatography

Removal of empty capsids is a particular goal of AAV purification. Multimodal PrimaT ligand offers new options for removal of empty and also damaged capsids. Besides it also contributes to...

Combining the Sensitivity of the PATfix Platform With the Resolution of Ultracentrifugation for AAV Characterization

Density gradient ultracentrifugation (DGUC) is a well established tool for Empty/ Full AAV capsid separation based on density differences between AVV sub-populations. However DGUC practice is laborious and lacks any...

Effect of Mg 2+ Ion Concentration on IVT Reaction Kinetics Determined by Novel Rapid Analytical HPLC Assay

The IVT reaction is one of the most expensive steps in mRNA production process and its optimization to reach high mRNA yield is of key importance. Standard mRNA quantification techniques...

Using PATfix Analytical Platform to Optimize Lysis Conditions in pDNA Downstream Processing

Optimizing processing steps in sc pDNA isolation is critical for obtaining good process yields as well as high product purity. PATfix platform with convective chromatography media (e.g. monolith) offers a...

CIM PrimaT | New Multimodal Ligand for Separation of Empty and Full AAV9 Capsids

AAV9 clarified harvest from Sf9 cells was concentrated and purified using combination of tangential flow filtration, nuclease treatment and cation exchange capture. First part was TFF coupled with Kryptonase treatment....

Two-Step Chromatographic Purification of pIVTeGFP-Transcribed mRNA With Post-transcriptional Capping

In mRNA production process, downstream purification of in vitro transcription (IVT) reaction often relies on precipitation methods which cannot provide resolution, recovery, or reproducibility to consistently produce a safe and...

High Yield mRNA Production Process From E. Coli to Highly Pure mRNA

The recently demonstrated efficacy of mRNA-based Covid-19 vaccines has shown promise of this therapeutic format, but also highlighted the need for higher efficiency of mRNA production to meet enormous needs...

Empty | Full Capsids Separation Using Three Different Modalities

Removal of impurities generated in the production of adeno associated virus (AAV) is an important step as they may pose a serious health risk, as well as deteriorate the economics...

Increasing Dynamic Binding Capacity of Oligo dT Using CIM 96 Well Oligo dT Plates

How to increase the binding capacity of Oligo dT18? Can a design of experiment approach be used to optimise Oligo dT binding? Is the monolith available in a high throughput...

Sample Displacement Chromatography for High Purity of Supercoiled DNA Plasmids

Sample displacement chromatography (SDC) is a chromatographic technique that utilizes differences in relative binding affinities of components in a sample mixture under chromatographic conditions. Here, we use SDC approach with...

Increasing the Productivity of IVT Reaction With HPLC Analytics

The cost of mRNA production is driven by IVT reagents, particularly the capping reagent. Optimization of mRNA yield is therefore crucial for lowering the cost of mRNA production. In order...

Scalable mRNA Purification Using PrimaS Multimodal Chromatography

CIM PrimaS column family combines multimodal anion exchange/hydrogen bonding properties, binding molecules with predominantly negative charge. It is used as capture method for purification of mRNA from IVT (in-vitro transcription)...

Matrix Effects on UV Determination of mRNA Content

Microvolume spectrophotometers are commonly used as quick and easy method to measure concentration and purity of nucleic acids. DSP process for purification of mRNA includes unit operations with salt concentrations...

Production Scale up of SDVB Monolithic Columns for the Purification of mRNA Molecules

Messenger RNA (mRNA) is becoming a major contributor in the fields of gene therapy and vaccines, including those developed in response to the COVID-19 pandemic. Convective Interaction Media (CIM) Styrene...

Monitoring mRNA Production Using CIMac Oligo dT Analytics

mRNA has been at the forefront of both scientific and general public interests from the start of the COVID-19 pandemic. The demand for the mRNA product has been incredible for the...

Effect of Matrix and Electrophoretic Conditions on Analysis of Linear pDNA

Agarose gel electrophoresis (AGE) analysis is an important method for monitoring of plasmid DNA (pDNA) quality, with ability to separate pDNA isoforms (sc, oc, lin, multimer). Plasmid linearization can be...

Influence of Chromatographic Parameters on Empty | Full AAV Separation

Monoliths are commonly used for separation of empty and full AAV capsids on analytical and preparative scale. PrimaS approach for AAV separation employs an ascending pH gradient, which can be sensitive...

CIM SO3 Monolithic 96-Well Plate for Fast and Efficient rAAV Capture Step Screening After Kryptonase-Tff Pretreatment

Standard 96-well design offers a great advantage for screening many samples or conditions and supports process automatization. Our approach was multi-parallel screening of different mobile phases for rAAV capture step...

Characterization of Various AAV Subpopulation Species, Separated by Multimodal Column PrimaT

In each adeno associated virus (AAV) downstream process one of the key steps is enrichment of full capsids. This could be achieved by density gradient ultracentrifugation however a main drawback...

Improvement of Empty | Full Resolution by Implementation of Novel Eluents Using PATfix

In every adeno associated virus (AAV) downstream process the key steps are the enrichment of full capsids and the in-process empty/full analytics. A common approach for enrichment of full capsids...

Chromatographic Platform for Characterization of mRNA Samples

mRNA has been at the forefront of both scientific and general public interests from the start of the COVID-19 pandemic. However, there are still limited options available for rapid characterization...

Implementing Chromatographic Methods for Evaluation of Large Scale Monolithic Columns for AAV Capsids Separation

Quaternary amine (QA) modified monolithic columns are frequently used for purification of therapeutically relevant adeno-associated virus (AAV) vectors, used in gene therapy. Beside process- and sample-derived variability, chromatographic material variability...

Role of Plasmid DNA Isoforms During Anion Exchange Chromatography

New development in the modern biotechnology increased the need for plasmid DNA (pDNA) with sizes above 10 kbp (large pDNA), but their chromatographic purification is often challenging due to low...

Gram-Scale mRNA Production Using a 250-mL Single-Use Bioreactor

The cost of mRNA production is driven by IVT reagents, particularly the co-transcriptional capping reagents. Optimization of mRNA yield is therefore crucial for lowering the cost of mRNA production. To...

Characterization of EVs Subpopulations From CIMmultus EV Using PATfix System

Cells release extracellular vesicles (EVs) of different sizes and intracellular origin. Due to their heterogenicity, the isolation of the target EV population from a mixture of supernatant-derived particles can be...

Purification of Newcastle Disease Virus Produced on a Novel Avian Cell Line CCX.E10

Newcastle disease virus (NDV) from the Paramyxoviridae family is a single-stranded, negative-sense, enveloped RNA virus of avian origin. There are many commercial vaccines based on live or inactivated virions that...

How to Operate CIM Well Plates With Vacuum Manifold

Chapters: 0:00 How to Operate CIM Well Plates With Vacuum Manifold 0:56 How to Properly Store CIM Well Plates

How to Operate CIM Well Plates With Positive Pressure Manifold

Chapters: 0:00 How to Operate CIM Well Plates With Positive Pressure Manifold 0:44 How to Properly Store CIM Well Plates

How to Operate CIM Well Plates With Centrifuge

Chapters: 0:00 How to Operate CIM Well Plates With Centrifuge 0:54 How to Properly Store CIM Well Plates

Practical Applications of CIM Monolithic Well Plates

Chapters: 0:00 Practical Application of CIM Well Plates 0:20 First Use 0:40 How to Prepare a Plate for Operation 1:05 Cleaning and Storage Procedure

PATfix Analytical System With Multiple Detectors | At-Line Monitoring

Are you waiting too long for analytical lab results to start improving your process? Do you know what really is happening in your process? Are you getting lower product yields...

Virtual Lab Tour | Viruses, Exosomes, and Virus Like Particles

A quick tour and presentation of the laboratory spaces of the department focusing on development for viruses, exosomes, and virus like particles at Sartorius BIA Separations in Slovenia. Our main...

Animation Flow Through The Monolith

BIA Separations Corporate Video

The right tool for the right task—and the skills to use it. That's who we are. We provide a unique technology customized for the special needs of purifying and analysing...

Improved Separation of AAV Capsids using AEX Chromatography

Strong anion exchange (AEX) chromatography is commonly used for separation of AAV capsids. The gold standard for target entities elution in ion exchange (IEX) chromatography is using an increasing salt...

Immobilized Enzymatic Reactors on Monolith Backbone for Rapid Plasmid Linearization

Immobilized enzyme reactors (IMERs) stand as innovative biotechnological constructs, seamlessly merging the catalytic proficiency of enzymes with the advantages of solid support matrices. Immobilized enzymes offer notable benefits such as...

Advancements in mRNA Synthesis | Real Time Quantification and Characterization of in Vitro Transcription Reactions Using Modified Nucleotides

The recent push to make a viable mRNA based vaccine against COVID 19 highlighted the significance of modified nucleosides, as one of the candidate vaccines failed precisely because only regular...

Monolithic Columns as Downstream Processing Solutions for Lentiviral Purification

Lentiviral vectors are efficient tools for transfer and stable integration of large gene inserts into the genomes of both dividing and non-dividing cells. Third generation of lentiviral vectors, which uses...

Enabling Tools for Purification and Understanding Complex Biomolecules Structure

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA Separations

Exosomes: New Tools for Industrial Purification and Process Monitoring

Speaker: Pete Gagnon, Sartorius BIA Separations

Cornerstone Technology for Purification of Clinical-Quality AAV

Cornerstone Technology for Purification of Clinical-Quality AAV.mpeg 39,75 MB

Analytical Methods: The Path to More Efficient Processes & Safer Gene Therapy Products

Speakers: Aleš Štrancar, Managing Director, Sartorius BIA Separations

A Cornerstone Platform for Industrial Purification of Exosomes

Speakers: Pete Gagnon, Sartorius BIA Separations

CIMmultus Monoliths – Tailored to Accelerate Process Development and Address Large Scale Manufacturing of ATMPs and Vaccines

Speakers: Ingo Nagler

CIMmultus Monoliths – Tailored to Accelerate Process Development and Address Large Scale Manufacturing of ATMPs like AAV, pDNA, mRNA or Exosomes

Speaker: Ingo Nagler

Purification of Single-Stranded mRNA: The Toolbox for the Next Generation

Abstract: Messenger RNA is poised to become a major contributor in the fields of gene therapy and vaccines. Making this a practical reality requires purification technology that accommodates its unique...

Chromatin (DNA) Removal From Harvest Before an AAV Capture Step Greatly Improves Robustness, Purity, and Yield of the Overall Downstream Process

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA SeparationsAbstract: Adeno associated virus (AAV) is the leading vector in the field of gene therapy because of its low toxicity, good overall safety...

Platform Purification of Clinical Quality Bacteriophage

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA SeparationsAbstract: Many of the most compelling applications of bacteriophages involve human therapy, some pertinent to gene therapy, others to antibiotic replacement. These applications...

High Yield mRNA Production Process from E.Coli to Highly Pure mRNA

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA SeparationsAbstract: Established processes for pDNA manufacturing include purification steps designed to enrich the supercoiled (sc) isoform. Homogeneous supercoiled isoform improves cell transfection efficiency...

Ways to Improve Empty, Full and Damaged Capsids Separation

This webinar features: Buffer optimisation and proper column ligand selection (CIM QA, CIM PrimaS or new CIM EF) allows for >90% full capsid production Introduction of Specimen allows for production...

Chromatographic Tools for High-Yielding mRNA Production Process & Integrated Production Process of mRNA From E. Coli to Highly Purified mRNA

Our new Head of Process Development for mRNA and pDNA purification, Rok Sekirnik, presented our Chromatographic tools for high-yielding mRNA production process as workshop. Our CEO, Ales Štrancar presented our...

Efficient, Robust and Scalable Purification of Covid Vaccines Based on pDNA, mRNA, Adeno and VLP Technologies

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA SeparationsAbstract: Adeno associated virus (AAV) is the leading vector in the field of gene therapy because of its low toxicity, good overall safety...

In-Process Analytics of AAV Vector Capsid Production

Speaker: Ivana Petrović Koshmak, Head of Upstream Process Development, Sartorius BIA SeparationsAbstract: In-process analytics of vector capsid production is a critical optimization target in development of AAV-based gene therapy products....

Unlock the Potential of the mRNA Vaccine Platform with Integrated Production Processes from E. coli to Highly Purified mRNA

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA SeparationsAbstract: A new purification approach starting from E.Coli all through to mRNA production is presented here. This new approach integrates a pDNA linearisation...

From E. coli to mRNA Drug Substance – Development of Analytical and Purification tools for a scalable mRNA production process

Speaker: Rok Sekirnik, Sartorius BIA SeparationsAbstract: This talk presents case studies of leveraging the power of at-line HPLC monitoring for process development to increase purity and yield of mRNA production....

Acceleration of AAV Manufacturing Process Development by Using Fast USP and DSP At-Line Biochromatography Analytics

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA SeparationsAbstract: Adeno associated virus (AAV) is the leading vector in the field of gene therapy because of its low toxicity, good overall safety...

All-in-one PATfix Analytical Platform

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA SeparationsAbstract: Global demand for pDNA production is at an all time high, due to increased need from Gene Therapy ramp-up. pDNA, as an...

FastFacts: Adenovirus Vector Manufacturing Platform Using CIMmultus QA Assures the Supply of Safe Vaccines

Watch the video or read the poster to learn: Why downstream processing remains one of the main bottlenecks in adenoviral vector manufacturing How an adenoviral vector purification platform using CIMmultus™ QA as...

Optimization of the AAV Expression Using PATfix Analytical Platform

Speaker: Ivana Petrović Koshmak, Head of Upstream Process Development, Sartorius BIA SeparationsAbstract: Adeno associated virus (AAV) is the leading vector in the field of gene therapy because of its low...

FastFacts: mRNA Manufacturing Platform Using CIMmultus® and CIMac Technology for High Recovery of Stable mRNA Drug Substance with Rapid HPLC Analytics

Watch the video or read the poster to learn: Non-affinity chromatography with PrimaS provides purification for IVT processes with co-transcriptional polyadenylation The Sartorius mRNA purification toolbox provides a scalable chromatographic...

FastFacts: Fast Chromatography of AAV – Purification and Analytics

Watch the video or read the poster to learn: Importance of sample pretreatment before first chromatographic step Rapid downstream process of AAV with emphasis on chromatographic step of CIMmultus SO3...

Speeding mRNA Process Development & Securing Robust Manufacturing by Using Fast In-Process Analytics

Speaker: Aleš Štrancar, Managing Director, Sartorius BIA Separations

Optimize Your mRNA Process from pDNA Template to LNP Encapsulation with a Single Analytical Platform

Speaker: Blaž Bakalar, Product Manager PATfix platform, Sartorius BIA SeparationsAbstract: mRNA-based therapeutics represent a promising new modality for therapies and vaccines. However, industry-wide process understanding of the CQA and CPP...

Optimize Your Process From pDNA Template to LNP Encapsulation With the Help of a Single Analytical Platform

Abstract: PATfix mRNA analytical platform is a perfect tool for process developers looking to optimize their mRNA production and purification Three orthogonal analytical methods based on mix-mode, affinity and reverse...

Reusability of CIM Columns

The document is presenting the reusability of CIM columns for preparative and analytical applications.

Method Development on CIM H-Bond Monoliths

H-Bond ADC is the first of a new class of chromatography ligands from Sartorius BIA Separations that exploits hydrogen bonding as the dominant mode of biomolecule retention. The ligand consists...

Purification of Influenza a Virus From Embryonated Chicken Eggs Using CIMac Adeno-0.1 Analytical Column

Influenza vaccines are still predominantly produced in embryonated chicken eggs and the purification processes barely have changed during the years. There is a growing need for fast, efficient and economical...

Increasing Productivity of pDNA DSP Using Sample Displacement Chromatography

Plasmid DNA (pDNA) as a pharmaceutical product has stringent purity and efficacy requirements, and often one or more chromatographic steps are used in the downstream process. High ligand density butyl-modified...

Application of PATfix SEC and CIM Anion Exchange Chromatography for Optimization of EV Upstream Production

Extracellular vesicles (EVs) are a diverse group of particles secreted by all living cells. Numerous different therapeutic applications of both native and engineered EVs are currently in different stages of...

AAV Manufacturing Process Development Using Fast USP and DSP Biochromatography Analytics

Key learning points: One of the key challenges in manufacturing viral vectors is to increase the ratio between empty and full capsids. When the expression in the cell line results...

mRNA: Removing Bottlenecks in Process Development and Manufacturing

Speaker: Rok Sekirnik, Head of Process development for mRNA|pDNA, Sartorius BIA SeparationsAbstract: In vitro-transcribed messenger RNA-based therapeutics represent a relatively novel and highly efficient class of drugs. Current clinical efforts...

Robust Manufacturing of Purer AAV Gene Therapy Vectors

Attend this webinar to learn how to achieve: 10% improved process recovery using the strong cation exchange instead of affinity column up to 2 fold shorter processing time using SO3...

Increasing Productivity of IVT Reaction Using At-Line Monitoring by HPLC Chromatography

In this webinar, we will discuss an HPLC-based analytical method using a multimodal ligand based on anion exchange/hydrogen-bonding ligand (PrimaS) to monitor the IVT reaction, which allows for simultaneous quantification...

Overview of Downstream Process of AAV Purification Using Monoliths and Rapid Evaluation of AAV Empty-Full Ratio with the PATfix System

Key learning points: Rapid downstream process of AAV using monoliths, with emphasis on PATfix analytical tools Orthogonal analytics are paramount for AAV characterization Integration using PATfix enables fast evaluation of...

Meeting Demand for Clinical Production of mRNA

Watch this webinar to learn about: How to ensure consistent and robust IVT production of mRNA How to achieve high yield and high purity in mRNA purification processes Chromatography solutions...

Increasing Productivity of IVT Reaction Using At-Line Monitoring by HPLC Chromatography

Watch this webinar to learn about: Benefits of implementing HPLC-based analytics in mRNA production workflow Principles of monolith chromatography and its use for mRNA analytics and purification Principles of IVT...

PATfix Analytical Platform for Monitoring mRNA Production Process

In this webinar, will discuss a robust analytical tool PATfix platform, and its specific methods for pDNA and mRNA analytics that enable efficient monitoring of key upstream and downstream process...

Chromatography in mRNA Production: From Analytics to Purification

Speaker: Rok Sekirnik, Head Process Development for mRNA and pDNA, Sartorius BIA SeparationsAbstract: The recently demonstrated efficacy of mRNA-based Covid-19 vaccines has shown the promise of this therapeutic format, but...

Cost Efficient Manufacturing of Purer AAV Gene Therapy Vectors

10% improved process recovery using the strong cation exchange instead of affinity column Up to 2 fold shorter processing time using SO3 instead of affinity column Less damaged capsids using...

Improved Capsid Purification in AAV Manufacturing

Speaker: Aleš Štrancar, Sartorius BIA SeparationsAbstract: Adeno-associated virus (AAV) capsids are an effective mechanism for delivering gene therapies intended for therapeutic use. A critical production step is the separation of...

New Methods to Separate Empty, Partial, Full and Heavy AAV Capsids

Learn how to achieve: Five times better resolution of empty/full capsids Large scale removal of empty, partial and heavy AAV capsids Batch-to-batch and scale-to-scale reproducibility within +/- 3% Speaker: Aleš...

New Empty|Full AAV Method Supported With Novel CIMmultus HR Columns to Enable Robust Manufacturing of AAV Products

Speaker: Aleš Štrancar, Sartorius BIA SeparationsAbstract: Separation of empty and full AAV capsids with almost same chromatographic characteristic request very high-resolution chromatography media and scale-to scale reproducibility within just few...

Chromatographic Tools for Isolation of Extracellular Vesicles and Process Monitoring Analytics

Speaker: Katja Vrabec, Project Manager, Sartorius BIA SeparationsAbstract: The development of fast and efficient processes for the isolation of extracellular vesicles (EVs) depends on the availability of chromatography media that...

Chromatography in mRNA Production: From Analytics to Purification

Speaker: Rok Sekirnik, Head Process Development for mRNA and pDNA, Sartorius BIA SeparationsAbstract: The recently demonstrated efficacy of mRNA-based Covid-19 vaccines has shown the promise of this therapeutic format, but...

Chromatographic Modalities, Buffer Selection and Other Considerations for Enrichment of AAV Product

Speaker: Rok Žigon, Head of Product-Application Area (AAV|Adeno), Process Development VirusesAbstract: Adeno-associated virus (AAV) is go-to vector for gene therapy treatments. In each AAV downstream process, one of the key...

Chromatography in mRNA Production From Analytics to Purification

Speaker: Rok Sekirnik, Sartorius BIA SeparationsAbstract: This talk presents case studies of leveraging the power of at-line HPLC monitoring for process development to increase purity and yield of mRNA production. It describes...

An Innovative Analytical Platform for Evaluating Vital LNP Characteristics

Speaker: Nejc Pavlin, Project Manager, Sartorius BIA SeparationsAbstract: Lipid nanoparticles (LNPs) have emerged as versatile drug delivery systems capable of encapsulating various payloads, including different nucleic acids. LNPs offer numerous...

Maximizing mRNA Production: At-line Process Monitoring for Improved Purity and Yield

Speaker: Rok Sekirnik, Sartorius BIA SeparationsAbstract: The talk will present case studies of leveraging the power of at-line HPLC monitoring for process development to increase purity and yield of mRNA...

Scalable Chromatographic Strategies for mRNA and saRNA Purification From IVT

Watch this webinar to learn about: Ins-and-outs of affinity chromatography for mRNA purification Challenges faced with purification of self-amplifying RNA Alternatives to affinity chromatography and their use in purification of...

Purification of pDNA Vaccine Against MDR Tuberculosis Using CIM Monoliths

Zunyang Ke, Yu Wang and Zhongming Li Anion-exchange chromatography is a key capture step in downstream processing plasmid DNA (pDNA). Separation of pDNA using traditional particle-based anion-exchange supports is usually...

Canine Adenovirus Downstream Processing Protocol

M. M. Segura, M. Puig, J. Piedra, S. Miravet Adenovirus: Methods and protocols, Methods in Molecular Biology, vol. 1089 Adenovirus vectors are efficient gene delivery tools. A major caveat with...

Datasheet | CIM Octa

CIM Octa columns are a high-throughput format for automated and parallel screening of chromatography conditions. Designed to be operated on a fully automated liquid handler with a needle. Columns come...

Improved Method for Full AAV Enrichment with CIMmultus QA HR

Discover a method guide for enhancing AAV enrichment and separation with QA HR line scalability.

Advanced AAV Polishing Purification: Ensuring Consistency, Scalability, and Purity with CIMmultus QA HR Columns

Explore an application note on AAV E/F separation with CIMmultus QA HR, ensuring reproducibility and scalability for robust manufacturing.

Exploring Solutions to Complex mRNA/LNP Therapeutic Challenges

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Optimization and Scale-Up Strategies for Purification of AAV and mRNA

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Increasing Yield of in Vitro Transcription Reaction With at‐Line High Pressure Liquid Chromatography Monitoring

Optimization and Scale up Strategies for Reproducible AAV Enrichment Step on CIMmultus QA HR Line

Learn how CIMmultus HR columns optimize AAV capsid separation and scalability in gene therapy.

CIMmultus HiP² Plasmid Process Pack Instruction Manual

Efficient pDNA and mRNA Purification With Our Simplified Processes

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Datasheet | CIMmultus Swiper

Explore Various RNA Modalities with CIMmultus® Swiper CIMmultus Swiper is a reusable, multimodal weak anion-exchange column for efficient RNA purification from acidic to neutral pH. It delivers high-yield, gentle purification...

Applicability of CIM Monolith Based Immobilized Trypsin Reactors for Continuous β-Lactoglobulin Hydrolysis

Simultaneous AAV8 Capsids and Impurity Fingerprinting in USP Using 2D Chromatographic Platform

Explore a 2D LC method for efficient AAV capsid monitoring and impurity analysis, optimizing upstream processes.

Analytical Separation of Plasmid DNA Isoforms Using Anion Exchanging Chromatographic Monoliths with 6 µm Channels

Comparison of Cation-Exchange Monoliths: CIM SO3 and Multimodal CIM SO4 Monoliths Using a Standard Protein Mixture

Particle Quantification of Influenza Viruses by High Performance Liquid Chromatography

J. Transfiguracion, A. P. Manceur, E. Petiot, C. M. Thompson, A. A. Kamen Vaccine (2014) The influenza virus continuously undergoes antigenic evolution requiring manufacturing, validation and release of new seasonal...