Part 1 Webinar Complete and Rapid Characterization and Assesment Candidate Biosimilars
As patents expire on the original innovator Biopharmaceutical molecules, biosimilars are entering the market and manufacturers are increasingly turning to analytical techniques for biosimilarity assessment. This three part webcast series describes the latest analytical workflows and key regulatory aspects for the characterisation of biosimilars.
In the first webcast of the series, Professor Yannis Francois will present recent developments in the use of CESI-MS technology for characterization of product quality attributes (PQAs) of monoclonal antibodies. He will show how this workflow may be used to accept or reject candidate biosimilars based on sequence coverage, glycosylation pattern, and post-translational modifications such as deamidation, oxidation and pyroglutamate formation.
Key Learning Objectives
Learn how to obtain 100% sequence coverage and information about the location, structure, and relative abundances of glycoforms
Discover how PTMs can be characterized and their relative abundances estimated from the same sample injection
Understand how candidate biosimilars were rejected based on quantitative glycan profiles and amino acid substitution resulting in sequence changes
Who should attend?
R&D, analytical development and Quality Control laboratory managers and staff at biopharmaceutical companies
Scientists and managers at contract organizations providing analytical services to the biopharmaceutical Industry
Academics collaborating with the biopharmaceutical industry
Professor Yannis Francois Laboratory of Mass Spectrometry of Interactions and Systems (LSMIS) UMR University of Strasbourg
Moderator: Laura Bush Editorial Director, LCGC