Manufacturing & Production
Sarepta Therapeutics and Catalent sign manufacturing deal for DMD gene therapy approval
Sarepta Therapeutics is a company focused on gene therapy, RNA and gene editing, engineering precision genetic medication for rare diseases. It has announced the signing of a commercial supply agreement with Catalent that will allow the company to manufacture delandistrogene moxeparvovec (SRP-9001), Sarepta’s most advanced gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD).
The FDA granted Sarepta its biologics license application (BLA) seeking accelerated approval for delandistrogene moxeparvovec in November 2022.
Catalent has state-of-the-art facilities that currently house ten cGMP gene therapy manufacturing suites, each capable of accommodating multiple bioreactors of up to 2,000L scale. Its UpTempo Virtuoso adeno-associated virus (AAV) platform is a scalable, GMP-ready process for viral vector manufacturing that can reduce a typical 18-month development timeline for a drug product by half.
Doug Ingram, Sarepta’s President and Chief Executive Officer said, “Sarepta is working as quickly as possible to advance new genetic medicines to treat progressive neuromuscular diseases like Duchenne and LGMD. We are excited to strengthen and expand our relationship with Catalent to meet anticipated demand for SRP-9001 and develop commercially scalable processes for additional gene therapy programmes in our pipeline. We appreciate the years of dedication and collaboration that Catalent has provided in supporting our clinical trials for SRP-9001, and we look forward to continuing our work together through this expanded partnership.”
“Our partnership with the Sarepta team spans nearly a decade across multiple programmes and modalities, and we look forward to working together to manufacture these potentially life-changing and life-saving products for patients diagnosed with DMD and LGMD. We look forward to leveraging our deep expertise in gene therapy development, manufacturing and commercialisation to support these programmes as they advance toward potential regulatory approval,” said Alessandro Maselli, Catalent’s President and Chief Executive Officer.