Why validation is key to the industrialization of cell and gene therapies

A particular challenge associated with commercializing a cell and gene therapy (CGT) product is defining and performing a successful process and product validation campaign. This is particularly challenging due to limited experience, data and guidance currently available for CGT products. BioPhorum’s CG&T validation workstream have published an article highlighting these issues, showcasing a number of unique validation challenges, and potential solutions, associated with CGT validation.

Sharif Ahmed of Bayer highlights some of these challenges, key takeaways/recommendations from the team, and the benefits of working as a cross-industry collaboration to discuss and identify potential solutions to common challenges.

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This deliverable has been published via the PDA website.

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