Taysha Gene Therapies, a clinical-stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for rare central nervous system disorders, and Catalent, a contract development and manufacturing organization (CDMO), have expanded their strategic partnership to include commercial manufacturing of Taysha’s investigational gene therapy for Rett syndrome (TSHA-102).

Under the agreement, Catalent will serve as Taysha’s primary commercial manufacturer following potential U.S. Food and Drug Administration approval of TSHA-102. Production will take place at Catalent’s FDA-licensed gene therapy facility in Harmans, Maryland, where the company will provide GMP manufacturing and commercial supply.

According to the companies, the agreement builds on a collaboration that began in 2020 and secures long-term manufacturing capacity and a scalable supply framework to support potential commercialization and future demand. Taysha said Biologics License Application (BLA)-enabling process performance qualification (PPQ) activities are currently underway as part of its manufacturing readiness strategy.

The agreement follows another expansion of Catalent’s gene therapy manufacturing business announced in July, when the CDMO broadened its partnership with Nanoscope Therapeutics to provide commercial-compliant packaging and distribution for MCO-010, an optogenetic gene therapy for retinal degenerative diseases, supporting the therapy’s late-stage clinical development and planned commercialization.