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Avoid CMC Challenges by Thinking Slow, Not Fast-Discussions at USP’s Workshop

The FDA Law Blog

NOVEMBER 1, 2022

Brevig, Senior Regulatory Device and Biologics Expert — On October 26, 2022, US Pharmacopeia (USP) Biologics Stakeholder Forum held a workshop on “Collaborating to solve CMC challenges and support efficient development of lentiviral-mediated CART cell therapies.” You also want your reference method to reflect the manufacturing process.

FDA 59
FDA Process Improvement 59
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Considerations for a Decentralized Manufacturing Paradigm

ISPE

SEPTEMBER 11, 2023

Summary from Advanced Manufacturing Technology Workshop Held at 6th Accelerating Biopharmaceutical Development Meeting.” Meeting Report: Joint BWP/QWP Workshop with Stakeholders in Relation to Prior Knowledge and Its Use in Regulatory Applications.” 5 , 13 , 27 , 32 1 US Food and Drug Administration. Advanced Manufacturing.”

Health and Personal Care Stores 52
Health and Personal Care Stores Vaccines Packaging Documentation 52
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