Comparative analytical data is at the foundation of any successful biosimilarity programme.
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.
- Measurement type: Molecular weight, Protein aggregation, Protein higher order structure, Protein stability, Molecular size
- Date: 18 May 2017
- 10:30-11:30 (GMT-05:00) Eastern [US & Canada]
- Event type: Webinar – Live
- Language: English