Catalent, Inc. and Sarepta Therapeutics, Inc. announced the signing of a commercial supply agreement for Catalent to manufacture delandistrogene moxeparvovec (SRP-9001), SareptaÆs most advanced gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD). The agreement also structures how Catalent may support multiple gene therapy candidates in SareptaÆs pipeline for limb-girdle muscular dystrophy (LGMD). In November 2022, Sarepta announced that the U.S. Food and Drug Administration (FDA) had accepted its biologics license application (BLA) seeking accelerated approval of delandistrogene moxeparvovec.

Under the terms of this expanded agreement, Catalent will be SareptaÆs primary commercial manufacturing partner for this therapy. CatalentÆs gene therapy network includes facilities that currently house 10 cGMP gene therapy manufacturing suites, with another 8 suites under construction, each capable of accommodating multiple bioreactors up to 2,000-liter scale. For gene therapy development, customers can leverage the companyÆs UpTempo Virtuoso?

adeno-associated virus (AAV) platform, a scalable, GMP-ready process for viral vector manufacturing that can reduce a typical 18-month development timeline for drug product by half. Catalent is also the only contract development and manufacturing organization (CDMO) with a facility approved by the FDA for commercial manufacturing of an AAV gene therapy.