UK accelerator secures cell and gene therapy production licenses
- The Cell and Gene Therapy Catapult, a U.K. accelerator, has been granted a number of licenses by the Medicines and Healthcare products Regulatory Agency (MHRA) to produce such therapies at its Stevenage manufacturing center, the company said Tuesday.
- The licenses, a manufacturing and importation authorization (MIA) and an MIA for investigational medicinal product (MIA IMP), are EU requirements for the creation of commercial medicines for use in patients and clinical trials.
- Those working at the manufacturing center include cell therapy developers Autolus, Cell Medica, and Adaptimmune, and gene therapy company Freeline — all of which are clinical-stage.
The Catapult's manufacturing center opened in April 2018. Funded by over £60 million (around $80 million) of the U.K. government's Industrial Strategy money, the center will provide current good manufacturing practice (cGMP) standard infrastructure for large-scale cell and gene therapy clinical studies, and to accelerate commercialization. It will operate on a collaborator model with the companies using its facilities.
"The granting of these licenses marks an important milestone for the CGT Catapult," CEO Keith Thompson said in a statement. "It demonstrates how our Stevenage manufacturing center is becoming one of the world’s leading facilities for the development and production of cell and gene therapies."
Thompson and his organization have worked with the MHRA to gain the necessary licenses for the facility.
"The award of these licenses in such a short timeframe is testament to the close engagement we have maintained with the MHRA … and one which we will continue to foster as the manufacturing center and its surrounding innovation cluster grows. We now look forward to working with our current collaborators as they leverage our licenses to move towards production of the first batches of clinical materials," said Thompson.
Adaptimmune, which has three T-cell therapy programs in clinical trials, signed a deal with Catapult in January, around the same time as it manufactured its first batch of SPEAR T-cells in-house.
"Having these dedicated resources both in-house and through external partnerships is essential to ensure our future success as a fully integrated cell therapy company," said James Noble, Adaptimmune’s CEO, at the time of the deal.
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