Application & Technical Notes
Resources
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...
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...
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...
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.
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.
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...
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...
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...
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...
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,...
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...
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...
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...
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....
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 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...
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)....