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This workshop is currently sold out; another session is offered 2-3 November 2021:
Ensure your manufacturing process consistently produces safe and effective biologics.All stages of the drug development life cycle require the proper adherence to chemistry, manufacturing and control (CMC) regulatory requirements. Join this two-day workshop for an introductory overview of CMC requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other highly regulated regions.The class is designed to orient professionals, managers and scientists responsible for biopharmaceutical CMC activities in the preparation of dossiers as well as an overview of some of the technical issues that must be addressed in biologic product development, registration, and lifecycle management.Topics will include:• Biological product characteristics• CMC regulations and guidance applicable to biologics• Quality by Design• Adventitious agents risk management• Source material, cell & seed banks• Upstream and downstream processing• Formulation and final product production• Characterization and testing• Demonstrating comparability
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