Taysha Gene Therapies, a clinical-stage biotechnology company focused on developing adeno-associated virus (AAV)-based gene therapies for rare, monogenic diseases of the central nervous system, and Catalent, a leading global contract development and manufacturing organisation (CDMO), have announced a commercial supply agreement for TSHA-102, Taysha’s investigational gene therapy in pivotal development for Rett syndrome, under which Catalent will serve as Taysha’s primary commercial manufacturer following potential US Food and Drug Administration (FDA) approval.
Building on a partnership that has supported the development of TSHA-102 since 2020, the agreement secures long-term commercial manufacturing capacity and a scalable supply framework to support a potential commercial launch and future demand. Catalent will provide GMP manufacturing and commercial supply of TSHA-102 at its FDA-licensed commercial gene therapy facility in Harmans, Maryland, leveraging its experience across more than 90 gene therapy programmes, including multiple commercial products.
