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Regulators Promote Early Process Understanding As Key To Success In Cell Therapy Manufacturing

 
• By Joanne S. Eglovitch

US and Canadian regulators espouse the need for early – and deep – knowledge of cell and gene therapy products as they progress through the pipeline to commercialization. Not doing so compromises product quality, and increases risks to patients.

Cancer Cells

Health regulators advise companies developing cell and gene therapy products to gather as much information early on in product development as possible and to build on this knowledge as these therapies progress through the pipeline from research to commercialization. Having this information early on leads to high-quality, consistent products that can be correlated to safety and efficacy.

Regulators discussed some of the complexities involved in manufacturing cell and gene therapy products and how to surmount these challenges at a July 17-18 meeting on cell and gene therapies...

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