Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.
|Articles|August 1, 2019
Gene Therapy Production Must Pass Regulatory Hurdles
Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.
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While researchers are succeeding with developing cell therapies and gene therapies, bringing technologies and processes to mass-produce the treatments, in an emerging and regulated environment, presents the biopharma industry with a unique set of challenges, says Eric Langer, managing partner, BioPlan Associates, in an interview with BioPharm International.
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