The Cell and Gene Therapy (CGT) Catapult said today it will partner with Freeline Therapeutics to build the gene therapy developer's proprietary manufacturing platform at the CGT Catapult’s large-scale GMP manufacturing center in Stevenage, Hertfordshire, U.K.
CGT Catapult is a U.K. government initiative created to advance the growth of the cell and gene therapy industry by bridging the gap between scientific research and large-scale commercialization. The U.K. has committed to building a £10 billion ($13.9 billion) cell and gene therapy industry.
Freeline develops gene therapies using engineered adeno-associated virus (AAV) vectors for the treatment of bleeding and other debilitating disorders. The platform was developed by founder and CSO Amit Nathwani, M.D., Ph.D., professor of Haematology at University College London (UCL), and is building on a successful hemophilia B Phase I/II trial conducted by UCL in collaboration with St. Jude Children’s Research Hospital, according to the company.
Freelance said it plans to deploy its manufacturing platform for production of a clinical supply in one of the CGT Catapult’s newly built manufacturing center modules.
“Ensuring rapid and secure manufacture of clinical supplies using cutting-edge manufacturing technologies has been an important focus for us since day one, as we have sought to build an agile business of industrial scale and quality,” Jan Thirkettle, Ph.D., Freeline's chief development officer, said in a statement. “Establishing this capability at the Catapult Manufacturing Centre enables us to meet this aim and to drive our growing pipeline forward.”
Last year, Innovate UK—the U.K. government's innovation agency charged with helping businesses develop and commercialize new technologies—awarded grants of £979,886 (about $1.4 million) to Freelance and £600,010 ($832,904) to CGT Catapult toward the project, titled “Establishing Freeline Commercial Scale Viral Gene Therapy Manufacture for Fabry Disease.” According to Innovate UK, the project had a start date of December 1, 2017, and has an end date of August 31, 2019.
“The recently confirmed grant from Innovate UK in support of this collaboration has been instrumental to expedite this important partnership,” Thirkettle added.
Building CMO Capacity
In applying for grant funding, Freeline said the manufacturing center's purpose included “removing Freeline's reliance on availability of severely restricted European CMO capacity (few capable of clinical and commercial).” Gene therapy developers and manufacturers have struggled as demand for viruses has grown to exceed available supply, compelling numerous companies to add capacity, alone or through collaborations.
The manufacturing center, scheduled to open in the first quarter of 2018, is designed to provide the U.K. with the manufacturing facilities needed for large-scale cell and gene therapy clinical studies and commercialization, in line with GMP standards, through a business model intended to allow the development of new manufacturing processes in a collaborative environment.
The center features a series of large cleanroom modules and is designed to enable companies to accelerate and scale manufacturing of gene therapies and collaborate on manufacturing and supply technologies needed to advance treatments into clinical phases.
CGT Catapult's 7200-square-meter (77,500-square-foot) manufacturing center consists of a GMP facility and support infrastructure designed to enable collaborators to carry out large-scale manufacturing of cell and gene therapies as they advance toward the market.
The £55 million ($76.3 million) manufacturing center is the world's first supported GMP manufacturing base for cell and gene therapies, according to Catapult. On August 30, Catapult announced plans to double the manufacturing center's current capacity, an expansion to be funded through a £12 million ($16.6 million) award from the UK Government’s four-year, £1 billion ($1.4 billion) Industrial Strategy Challenge Fund.