Publications
Resources
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.
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.
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...
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.
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...
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...
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.
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.
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)...
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...
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...
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...
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...
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....
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...
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...
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...
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...