Catalent has five gene therapy facilities in Maryland that provide clinical- through commercial-scale services, and house multiple CGMP manufacturing suites, including fill/finish, central services and testing laboratories, warehousing, and supply chain capabilities
Taysha Gene Therapies and Catalent have announced a partnership to support the development and manufacturing of Taysha’s gene therapies at Catalent’s Maryland-based gene therapy facilities.
“Through this partnership, we will be able to enhance our existing manufacturing capabilities to support Taysha’s broad gene therapy pipeline,” said RA Session, II, President, Founder and CEO of Taysha. “We are focused on ensuring that we can provide access to potentially curative gene therapies for thousands of patients by establishing this robust infrastructure early.”
Taysha has a partnership with UT Southwestern Medical Center that allows it to access the institution’s CGMP manufacturing suite, which has a capacity of more 500 litres as well as 100-litre toxicology material capacity.
In addition, the company intends to establish its own commercial-scale, CGMP manufacturing facility to meet future demand for its gene therapy product candidates. The partnership with Catalent is aimed to to rapidly expand Taysha’s manufacturing capacity and will support future manufacturing needs for several of its gene therapy programs, including treatments for CLN1 and Rett syndrome.
“Given Taysha’s large and growing pipeline of gene therapies, we wanted to plan for potential increased manufacturing needs above the GMP facility at UT Southwestern and our own planned manufacturing facility,” said Fred Porter, Chief Technical Officer for Taysha. “We believe that this partnership is critical to our strategy for future clinical and commercial supply of our gene therapy product candidates.”
“Catalent is committed to gene therapy partnerships at all stages of development and manufacturing,” commented Manja Boerman, President, Catalent Cell & Gene Therapy. “With our experience in process and analytical development and deep expertise in adeno-associated viral vectors, combined with our growing footprint, we are able to help companies manufacture patient material and reach the clinic faster.”