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Andelyn Biosciences to Offer Faster Gene Therapy Development

FDA accepts GMP plasmid DMF and capacity expansion enabling.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Andelyn Biosciences, a cell and gene therapy contract development and manufacturing (CDMO) born out of Nationwide Children’s Hospital, said that the U.S. FDA has accepted 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.   Most of today’s gene therapies—including adeno-associated virus- and lentivirus-based thera...

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