Speaker in this video:
Ms Sheetal Raut, Sr Manager and Bioassay Team Lead – Advanced Biotech Lab, Ipca Laboratories
Topic: Evolving functional characterization strategies in the era of monoclonal antibody development
Key Highlights:
[1] Functional characterization is crucial in the development and regulatory assessment of mAb biosimilars. Confirms that it possess equivalent biological activity and potency compared to the reference product by measuring binding affinities, cell-based responses, and effector functions.
[2] Provides robust justification for biosimilar approval by addressing regulatory expectations for analytical similarity and effectiveness, especially when clinical data is limited.
[3] Offers essential data for post-approval lifecycle management, process changes, and ongoing comparability studies throughout the product’s lifespan.