CLINICAL SUPPLY MANUFACTURING ARTICLES

cell culture dish-GettyImages-1592382581 When Does GMP Matter In Non-GMP Settings?

Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.

CLINICAL SUPPLY MANUFACTURING VIDEOS

Christina Yi, Chief Operating Officer at Vaxxinity, vaccine commecialization expert Kimberly Murphy, and Valneva Chief Medical Officer Dr. Juan Carlos Jaramillo discuss the biggest manufacturing challenges they face as they work quickly to develop clinical supply of next-generation vaccines and commercial supply of existing product. The supply chain proves chief among those challenges. In this segment of our recent BioProcess Online Live! event Manufacturing Vaccines On COVID's Coattails, the two discuss how these challenges have impacted timelines, how they're solving those challenges at Vaxxinity and Valneva, and lessons learned during the COVID-19 pandemic that they'll carry into the future.

Susan Dexter, Chief Technical Officer, Sonnet BioTherapeutics, describes the good choices she made, and one not-so-good choice, in trying to untie a knotted supply chain.

If you are in the process of developing a complex or sensitive injectable drug, learn about containment solutions to mitigate your risks and help you get your drug to the patient faster.

Tony Sampognaro, Director, CMC Project Management, Stoke Therapeutics, recalls a rather harrowing experience involving a CMO and Clinical Operations failure to communicate.

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