Catalent Gene Therapy Facility Receives FDA Approval as an Additional Manufacturing Site for AveXis' Gene Therapy
Catalent, Inc. (CTLT)
Last catalent, inc. earnings: 2/3 07:30 am
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Source: PR Web
SOMERSET, N.J. (PRWEB) August 06, 2020 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it was approved by the U.S. Food and Drug Administration (FDA) to produce commercial drug substance intermediate for AveXis' spinal muscular atrophy (SMA) gene therapy at its manufacturing facility located in Harmans, Maryland.The approval comes after an FDA inspection of the Harmans state-of-the-art, commercial-scale gene therapy manufacturing center in June 2020. Since Catalent's partnership with AveXis, a Novartis company, was announced in July 2019, dedicated suite space has been prepared at the Harmans facility for the commercial manufacture of this adeno-associated virus (AAV) gene therapy."This is a significant milestone for Catalent and the gene therapy industry as a whole. Catalent is proud to be the first contract development a
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