Charge Variant Analysis of Biotherapeutics: Evolving methods from Characterization to Commercialization

Biotherapeutic proteins are by their very nature charged molecules. Charge based profiling of biotherapeutic proteins is used to establish product identity, product heterogeneity, and product purity. Charge based separations, including Ion-Exchange chromatography and capillary electrophoresis, are now commonly employed to resolve protein variants by their charged nature. Ion exchange chromatography possesses several advantages in format, enabling selective resolution of variants based on spacial charge distribution rather than overall net charge, and the capability for fractionation of charge-based variants for in depth characterization and activity profiling. More recent capabilities for online coupling to mass spectrometric detection has enabled rapid assignment of variants, and tracking those species as methods are further developed and optimized.

In this webinar, we will cover workflows that simplify the development of biotherapeutic charge variant separations, including those methods developed to be compatible with online MS detection. The translation of these characterization analyses to optical detection methods that can be employed more routinely for charge variant monitoring will be described. The evolution of these routine method to even a simpler optimized method for use in manufacturing and quality will be covered in this presentation.

Please join us in this live, and recorded event to learn:

• An efficient methodology for developing online IEX-Native MS methods for charge variant characterization.
• The translation of these methods into optical detection methods for charge variant monitoring.
• The simplification of charge variant methods for deployment into routine process monitoring and product release assays.

Who should attend this webinar:

• Scientists charged with biotherapeutic protein characterization
• Analysts charged with developing these methods
• Organizational management charged with transfer of these assays
• Contract organizations tasked with delivering these methods and results to customers

Presenter: Robert Birdsall (Consultant Scientist, Waters Corporation)

Robert received his PhD in analytical chemistry from Purdue University, where he developed chromatographic methods in the characterization of proteins using sub-micron silica-based substrates. He joined Waters in 2013 as part of Scientific Operations and is currently leading a team of scientists providing analytical support in the development, commercialization, and application of Waters Technology.