- Taysha Gene Therapies has entered into a commercial supply agreement with Catalent for TSHA-102, its investigational gene therapy for Rett syndrome.
- Catalent will serve as Taysha’s primary commercial manufacturer following potential FDA approval, providing GMP manufacturing and commercial supply from its Maryland facility.
Taysha Gene Therapies has entered into a commercial supply agreement with Catalent under which the contract development and manufacturing organization (CDMO) will become the primary commercial manufacturer of TSHA-102, Taysha’s investigational gene therapy for Rett syndrome, following potential U.S. Food and Drug Administration (FDA) approval. The agreement builds on a collaboration between the companies that began in 2020 and is intended to provide long-term commercial manufacturing capacity and a scalable supply framework to support a potential product launch.
Under the agreement, Catalent will provide GMP manufacturing and commercial supply of TSHA-102 from its FDA-licensed gene therapy manufacturing facility in Harmans, Maryland. The company said it will leverage its experience across more than 90 gene therapy programs, including multiple commercial products, to support production of the adeno-associated virus (AAV)-based therapy. The agreement expands Taysha’s commercial infrastructure as the company advances TSHA-102 through pivotal development.
“As we continue to advance TSHA-102, establishing long-term commercial manufacturing capacity is a critical component of our launch readiness strategy. Catalent’s deep gene therapy expertise and proven commercial manufacturing capabilities make them an ideal partner as we expand our partnership to further strengthen our commercial infrastructure with a reliable, scalable supply framework.”
Sean P. Nolan, Chairman and Chief Executive Officer of Taysha
According to the companies, BLA-enabling Process Performance Qualification activities for TSHA-102 are underway. Catalent said the partnership reflects its strategy to provide end-to-end CDMO and contract manufacturing services for cell and gene therapies, supporting developers from product development through commercialization for rare disease treatments.
