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Sophia Kenrick, PhD,* is an application scientist at Wyatt Technology Corporation, 6300 Hollister Ave, Santa Barbara, CA 93117-3253.

Articles

Quantifying AAV Quality Attributes Using SEC–MALS

The benefits of a robustness assessment for the analysis of a NIST mAb using a wide pore C4 LC column are described.

Method Robustness and Reproducibility for Monoclonal Antibody Purity Analysis

A review of the current state of HIC, focusing on retention and separation mechanisms with the aim of developing more robust methods. Can HIC be considered as a non-denaturing and non-destructive technique with advantages for protein analysis?

Hydrophobic Interaction Chromatography (HIC) for the Characterization of Therapeutic Monoclonal Antibodies and Related Products, Part 1: Theoretical Aspects

New analytical workflows are needed to address the advances in biopharmaceutical product composition. A description of the multi-attribute method (MAM) is given, which has been developed to monitor critical quality attributes (CQAs) simultaneously and directly.


The Multi-Attribute Method (MAM) for the Characterization of Biopharmaceuticals

IMS is a valuable tool for biopharmaceutical analysis. Two formats in particular have proven useful: cyclic IMS and structures for lossless manipulations (SLIM).

Ion Mobility Spectrometry (IMS): How It Works and Its Use in Biotechnology

Florian Füssl received his Dr. rer. nat. degree from the University of Salzburg, Austria. Since 2016 he has been a postdoctoral researcher in the Characterization and Comparability Laboratory of Jonathan Bones at NIBRT in Dublin, Ireland. His main focus is the development of novel methods for the characterization of complex biopharmaceuticals using liquid chromatography–mass spectrometry (LC–MS) 

techniques with special emphasis on intact native protein analysis.

Lisa Strasser holds a PhD from the University of Salzburg, Austria. In 2019 she joined the National Institute of Bioprocessing Research and Training (NIBRT), based in Dublin, Ireland, where she was using LC–MS based proteomics to study host cell proteins. Now she is working on the characterization of adeno‑associated viruses (AAVs) for the purpose of gene therapy.


Sara Carillo is the applications development team leader in the Characterization and Comparability Laboratory in NIBRT, Ireland. Sara completed her PhD in Chemical Science at the University of Naples in 2013 working on bacterial glyco‑conjugates structural characterization. In 2015, Sara joined Jonathan Bones’ research group in NIBRT, working on CHO cell glycome and biotherapeutics characterization.

Jonathan Bones, PhD, is principal investigator at NIBRT.

This article explores the potential of microchip capillary electrophoresis–mass spectrometry (CE–MS) for the characterization of intact biopharmaceuticals, and how this technique can effectively be employed to monitor essential quality attributes of interest.


Exploring Capillary  Electrophoresis–Mass Spectrometry for the In-Depth Intact Native Analysis of Cysteine-Conjugated Antibody-Drug Conjugates

Wolfgang Esser-Skala is a postdoctoral researcher at the Christian Doppler Laboratory for Innovative Tools for Biosimilar Characterization at the University of Salzburg, Austria. He primarily develops algorithms and workflows for analyzing mass spectrometric data on post-translational modifications found in biopharmaceuticals.

This article explores the analytical challenges associated with HCP monitoring and reviews recent advances in HCP characterization, with special emphasis on high performance liquid chromatography mass spectrometry (HPLC–MS)-based methods and HCP enrichment techniques.

In Search of The Needle in The Mariana Trench: Host Cell Proteins and the Problem of Dynamic Range

Christina Jayne Vanhinsbergh is a researcher at the University of Sheffield, UK. Her Ph.D. research focused on the development of multidimensional chromatographic methods for the analysis of therapeutic oligonucleotides. Currently, she is researching DNA alkylation from environmental compounds using LC–MS methodologies. Christina is the membership officer for the Chromatographic Society, UK.

The diverse nature of oligonucleotide therapeutics leads to the requirement for multiple separation methods to characterize quality attributes. Highly chemically-modified to improve efficacy and resilience to nucleases, they are challenging to analyse using a single method. This article discusses multiple chromatographic separation methods, and the benefits of mass spectrometry (MS).

Analytical Separation Methods for Therapeutic Oligonucleotides

Collin Hauskins began his career at Zymogenetics and Novo Nordisk working on a range of immuno‑oncology programmes. Collin has been at Juno Therapeutics, a Bristol Myers Squibb company, since 2014 and currently leads the Raw Materials Group. His team is responsible for developing analytical methods for raw materials used in the manufacture of CAR-T cell therapies.

Hai Yue is a Principal Scientist in the Product and Analytical Department in Cell Therapy Development and Operations at Bristol Myers Squibb in Seattle, Washington, USA. Prior to his current position, he worked at Amgen Inc. as a Scientist in Process Development for four years. Hai received his Ph.D. in Biochemistry from Washington University in St. Louis, USA.


Richard S. Rogers is a Principal Scientist in the Product and Analytical Department in Cell Therapy Development and Operations at Bristol Myers Squibb. At BMS, Richard leverages mass spectrometry to characterize viral vector and CAR-T cell drug product. He received his Ph.D. in Biochemistry and Molecular Biology from the Johns Hopkins University, USA.


Cellular and gene therapies (CGTs) have contributed significantly to the improvement of clinical outcomes for patients in the recent years. This paper discusses a range of physicochemical methods that play an important role in the difficult characterization of viral vectors, to meet the unique needs of CGT manufacturing process development, process and product characterization, and the quality control testing of these materials.

Physicochemical Methods for Vectors and Ancillary Materials in Cellular and Gene Therapies 

Jane Luo is a staff applications scientist in the Applied Biologics Workflow Development group at Sciex. She earned her PhD in Biochemistry from the City University of New York, USA, received postdoctoral training on Molecular Biology and Cell Biology at Weill Cornell Medical College and Harvard Medical School, and performed cancer research as an assistant adjunct professor at UC Irvine, USA. In 2002, she moved to industry to develop capillary electrophoresis‑based products and applications.


In this paper, two adeno-associated virus (AAV) genome integrity analysis workflows are introduced; a standard sample preparation protocol and an accelerated procedure, both utilizing capillary gel electrophoresis with laser induced fluorescent detection (CGE–LIF) to analyze the released nucleic acids.

Biopharmaceuticals and Protein Analysis | Topics