A successful biosimilar program 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.

This webinar will present comparative SEC data collected using Malvern's OMNISEC system on a number of innovator monoclonal antibodies and biosimilar molecules, and discusses the impact of different formulations and external stress conditions on these products.