FDA Accepts GMP Plasmid DMF and Capacity Expansion Enabling Andelyn Biosciences to Offer Faster Gene Therapy Development
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COLUMBUS, Ohio, Jan. 13, 2022 /PRNewswire/ -- Andelyn Biosciences, a pioneering cell and gene therapy CDMO born out of Nationwide Children's Hospital, today announced the U.S. FDA's acceptance of its GMP plasmid DNA drug master file (DMF), which enables the organization to vertically integrate its clients' manufacturing process, condensing timelines for developers to begin manufacturing to just three months.

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