Season 4: Episode 4 - Challenges in CMC Development of Biologics/Biosimilars

Streamlined biologic product development involves proper Regulatory assessment and overcoming challenges encountered during the CMC development phase. This episode will discuss the challenges faced during complex biological product development.

Furthermore, our experts will express their Regulatory views on variability in batch-to-batch testing, impurities testing, viral load clearance, and factors encountered in the biological product arena.

To know more about the Season 4, visit: https://www.freyrsolutions.com/regulatory-radio/season-4-eu-regulatory-pathways-for-biological-products