A new webinar by Malvern evaluates and discusses size-exclusion chromatography (SEC) data to see the impact of different formulations on monoclonal antibodies and biosimilar molecules.
A successful biosimilar programme has comparative analytical data at its foundation. As part of the analytical study, regulators require the use of state-of-the-art technology to compare the innovator and biosimilar higher order structures, including aggregation, in addition to any formulation effects on purity, stability, and product and process related impurities.
Multi-detection SEC is a key tool in demonstrating biosimilarity, as it allows the absolute molecular weight, oligomeric state, purity, and size of a monoclonal antibody to be measured in a single injection.
Malvern’s webinar will present comparative SEC data collected using Malvern’s OMNISEC system on a number of innovator monoclonal antibodies and biosimilar molecules.
The webinar will take place on 18 May from 10:30 to 11:30 GMT-05:00 (Eastern US and Canada time).
Speaker John Stenson is Malvern’s product technical specialist for SEC. He works with SEC-related detector systems, including the company’s OMNISEC and Viscotek product lines. John’s key interest lies in using Malvern technologies to investigate the properties of proteins and biopolymers.
Who should attend?
Formulation scientists, biosimilar scientists, lab managers, and research and development (R&D) scientists will benefit from this webinar. You will be provided an understanding of how multi-detection SEC can be used to create robust comparability profiles of monoclonal antibodies and their biosimilar molecules.