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Catalent’s Harmans Site Approved to Manufacture AveXis’ Gene Therapy

To produce commercial drug substance intermediate for AveXis’ spinal muscular atrophy gene therapy at its manufacturing facility in Harmans, MD.

By: Contract Pharma

Contract Pharma Staff

Catalent was approved by the U.S. FDA to produce commercial drug substance intermediate for AveXis’ spinal muscular atrophy (SMA) gene therapy at its manufacturing facility in Harmans, MD.  The approval follows an FDA inspection of the Harmans commercial-scale gene therapy manufacturing center in June. Under Catalent’s partnership with AveXis, a Novartis company, a dedicated suite space has been prepared at the Harmans facility for the commercial manufacture of this adeno-associated virus (A...

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