Taysha Gene Therapies to open new cGMP facility

Taysha Gene Therapies, Inc., which focused on developing adeno-associated virus (AAV)-based gene therapies for the treatment of monogenic diseases, has entered into a lease agreement for an approximately 187,000-sq.-ft. current Good Manufacturing Practices (cGMP) manufacturing facility in Durham, NC. The company will invest $75 million and create an estimated 200 jobs over two and a half years.

Multiple production suites are expected to be completed by 2023, and will allow production that is compliant with FDA guidelines. The facility will feature 2,000 liters of capacity—additional reinforcements aside from Taysha’s existing manufacturing agreements with UT Southwestern’s gene therapy program and Catalent—and will be designed to support all aspects of scalable manufacturing of gene therapy material to meet both clinical and commercial demand.

The company plans on having four open investigational new drug (IND) applications in 2021.