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Cell and Gene Therapy: CMC and Manufacturing Hurdles and Solutions 

Maryland Tech Council
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Manufacturing of cell and gene therapy is the bottleneck for availing this line of innovative therapies to clinical trials and patients. In this panel, we invited the world experts in cell and gene therapy to address Chemistry, Manufacturing and Controls (CMC) aspects of cGMP manufacturing of cell and gene therapy. The topics include quality by design, scaleup, process control, and product characterization and release. The goal for the panel is to share insights on how to design CGT product and production processes to allow for quality and speedy release.
Moderator
Jeffrey Hung, General Manager, Vigene Biosciences
Panelists
Matthew Hewitt, B.A, PhD, Senior Director, Scientific Solutions, Cell and Gene Therapy, Charles River Labs
David Anderson, Senior Director, Quality Site Head, Kite, a Gilead Company
Jon Rowley, Chief Product Officer, RoosterBio

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6 авг 2024

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