CLINICAL SUPPLY MANUFACTURING ARTICLES

Earth Diverse unity-GettyImages-2189085103 Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots

The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

CLINICAL SUPPLY MANUFACTURING VIDEOS

Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.

Expert speakers discuss current operational obstacles and explore strategic solutions to optimize a supply chain strategy in the years ahead.

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.

Scale your biologic fill-finish from vials to autoinjectors without disruption. See how integrated device assembly capabilities support every clinical phase through commercialization.

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