Characterization of Biotherapeutics


24th September 2019 | 10.00 am EST | Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia and Dr Kai Scheffler, Product Manager at Thermo Fisher Scientific |WATCH FOR FREE

Biotherapeutic products are typically characterized by multiple orthogonal methods to evaluate product quality and purity, including assessment of aggregates, variants, and degradation products. For monoclonal antibodies and many other biotherapeutics, analysis of post-translational modifications, such as glycosylation, are also important since these modifications can impact the efficacy, stability, and safety of the final product. This presentation will provide an overview of methods and standards used during characterization, with an emphasis on monoclonal antibodies.

Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia 

Dr. McCarthy is a Senior Manager, Science and Standards within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.

Followed by Charge Variant Separation Coupled to High Resolution Mass Spectrometry for Routine mAb Analysis

Biotherapeutics such as monoclonal antibodies are a heterogeneous mixture of structurally similar molecules that differ in mass and charge, referred to as charge variants. Charge variants result from sequence variations and post-translational modifications such as e.g. deamidation and sialylation resulting in species that are more basic or acidic than the main mAb monomer. The heterogeneity can be revealed by charge-sensitive separation methods, such as ion exchange chromatography. The use of MS-compatible buffers allows for online hyphenation to a mass spectrometer. This hyphenated setup provides the chromatographic resolution of ion exchange chromatography coupled to the identification of the separated variants by mass spectrometry.
In this webinar we will discuss a charge variant analysis (CVA) workflow that entails ion exchange chromatography using pH gradients for protein elution with online mass detection on a high resolution Orbitrap-based mass spectrometer. This workflow enables routine application to a wide range of antibody samples for comprehensive analysis based on a single injection without the need for sample preparation.

Presented by Dr Kai Scheffler, Product Manager at Thermo Fisher Scientific

Kai Scheffler is a chemist by training, holding a PhD in Biochemistry. He has focused on the characterization of carbohydrates, peptides and proteins throughout his entire professional career. Out of the variety of chemical, biochemical, microbiological and analytical methods and techniques and technologies he had applied, mass spectrometry became the one he got most fascinated by and thus has continuously deepened his skills and experience over the course of the past 22 years. He joined Thermo Fisher Scientific in 2004 – one year before the first commercially available Orbitrap-based mass spectrometer was introduced into the market. As support specialist for the Proteomics market at first and BioPharma a few years later, Kai has educated and supported users on the different Orbitrap mass spectrometer generations that were introduced in the past 15 years. He developed many relevant LC-MS applications for the analysis of proteins and peptides and in particular antibodies and antibody-drug conjugates on the intact, subunit and peptide levels. In his current role as Product Manager he is engaged in fruitful collaborations aiming to further develop analytical LC-MS methods and technologies matching the advancing needs and requirements of the BioPharma market.

Sponsored by Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.


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