08.08.19 -- Roundtable Discussion Reveals Biggest Biosimilar Knowledge Gaps

Though this event encompassed a small cross-section of employers, the discussions and questions asked about biosimilars revealed the topics that need to be considered, reiterated, and regularly reinforced.

Whether Inter Partes Review (IPR) is the right choice for biosimilar developers will depend on the particular circumstances surrounding each drug candidate. But given the benefits of IPR proceedings, they must at least be considered as a potential tool for challenging patents.

Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.

Protein A affinity purification has multiple limitations in terms of productivity at manufacturing scale and the costs associated with making commercial antibodies, especially biosimilars.