Taysha Selects Catalent as Primary Manufacturer of TSHA-102 Following Potential FDA Approval
Taysha Selects Catalent as Primary Manufacturer of TSHA-102 Following Potential FDA Approval
On August 3, Taysha announced an agreement with Catalent: if the FDA approves TSHA-102, Catalent will become the primary commercial manufacturer of this gene therapy for Rett syndrome. Production is being prepared at Catalent’s FDA licensed facility in Harmans, Maryland.
Mutations in the MECP2 gene cause Rett syndrome. This gene helps neurons regulate the activity of other genes. A child with the condition may lose speech and hand skills, then later develop problems with movement and breathing. TSHA-102 is administered once into the cerebrospinal fluid. An AAV9 vector delivers a shortened, functional version of MECP2.
The ClinicalTrials.gov registry lists the REVEAL study as active and closed to enrollment. It includes 17 girls and women with Rett syndrome from 6 to 21 years of age, each of whom receives one injection. Over 52 weeks, physicians assess the proportion of participants who gain or regain at least one of 28 predefined developmental skills.
Taysha and Catalent have worked together since 2020. Their previous partnership covered the development and manufacturing of several AAV therapies, including the Rett syndrome program. The new agreement links future commercial supply to a single therapy and identifies its manufacturer and production site in advance.
Taysha has already begun process performance qualification (PPQ), which is required for a future biologics license application. During this work, the manufacturer determines whether the defined process can consistently produce batches that meet specified quality attributes. For a gene therapy, manufacturing is part of the product itself: each new batch must meet the same specifications as the previous one.
The agreement gives Catalent a specific task: prepare routine production of TSHA-102 for patients once the FDA approves the therapy. For a one time treatment, the manufacturer must consistently produce the same genetic construct with the same quality attributes.