BioPhorum report 2019

This year’s report focuses on industry trends, current and emerging issues, and workstream results from across the Phorums. We look at how the development and recent launch of the alignment model helps to promote alignment across SMEs, leaders and executives roles, enabling senior sponsorship, providing best-practice approaches to drive implementation and communication, and enhancing benefit realization from workstreams. The Development Group takes us through significant updates from bioassays to small-scale models to viral clearance. While collaboration is at the heart of a story on PUPSIT (Pre-Use Post-Sterilization Integrity Testing), which focuses on how BioPhorum and the PDA are working with members to accelerate an industry response to an EU directive. We also discover how a meeting with the FDA supports momentum to foster regulatory discussions and hastens the adoption and successful implementation of advances in microbial control manufacturing and technology.

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