Clarity in cell line development

An Interview with Audrey Jia, former FDA CMC Reviewer for Biological Products

In a two-part series of interviews commissioned by Solentim, Dr Audrey Jia; a former USFDA CMC Reviewer for Biological Products, was questioned on the key topic of regulatory compliance for the determination of clonality in cell lines producing therapeutic proteins. The intention of the interviews was to gain some objective, independent advice from an industry …

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