TrakCel said today it will incorporate its needle-to-needle supply chain management platform into the Cell and Gene Therapy (CGT) Catapult’s large-scale cell and gene therapy manufacturing center set to open this fall in Stevenage, U.K.

CGT Catapult is a U.K. government initiative created to advance the growth of the U.K’s cell and gene therapy industry by bridging the gap between scientific research and full-scale commercialization.The U.K. has committed to building a £10 billion ($13 billion) cell and gene therapy industry.

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 ($72 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 ($15.7 million) award from the U.K. Government’s four-year, £1 billion ($1.3 billion) Industrial Strategy Challenge Fund.

CGT Catapult said its partners in academia and industry will be able to use a software solution intended to track cell therapies across the whole supply chain, completely integrated within validated systems at the manufacturing center as well as at associated cryostorage and logistics facilities.

“This integration of GMP manufacturing, cryostorage, and logistics support within a complete end-to-end supply chain management solution is something that has not been done before and is critical to enabling commercial supply of cell and gene therapies in the U.K.,” Keith Thompson, CGT Catapult’s CEO, said in a statement.

Real-Time Records

TrakCel’s platform is designed to provide real-time audit logs and chain-of-custody records, reducing the risks associated with disparate, paper-based systems, and thus accelerate the scale-up and scale-out of cell therapy processes. The platform will also be able to link with any other commercially available or custom-developed tracking systems employed by future partners, according to CGT Catapult.

In addition to the manufacturing center, TrakCel’s technology will also link to Thermo Fisher Scientific’s new Fisher Bioservices CryoHub(SM), being built adjacent to the manufacturing center warehouse. Located an hour from London’s Heathrow Airport, the Cryohub will provide services for distribution of patient sample collection sets, cGMP cryo-storage of cell and gene therapies, and also cryo-logistics for supply of these therapies throughout the U.K. and beyond.

“This partnership between CGT Catapult, TrakCel, and Fisher BioServices will deliver the most technologically advanced and secure large-scale GMP manufacturing base for cell and gene therapies in the world,” declared TrakCel CEO Ravi Nalliah. “The cell therapy sector is now starting to move from considerations around clinical development to commercialization and multilayered supply chains involving many more patients, individuals, and organizations. Patients will rely on the sector to ensure supply chains involve the adequate transportation of valuable cellular material in the right conditions.”

CGT Catapult said it selected TrakCel because its platform is established and has already been installed and validated at sponsors, clinical sites, CMOs, and logistic partners across North America and Europe.  

Founded in 2012, TrakCel designs and develops integrated technologies for managing autologous and allogeneic cell, gene, and immunotherapy supply chains. In addition to CGT Catapult, users of TrakCel’s include GlaxoSmithKline (GSK), Autolus, Caladrius Biosciences, Miltenyi Biotec, and Oxford BioMedica.

TrakCel is headquartered in Cardiff, Wales, U.K., with U.S. offices in Dinuba, CA, and Bridgewater, NJ. The company says it aims to employ over 100 people in the U.S. and U.K. by the end of 2019 and has appointed several executives to senior positions since last year—including Joe Vitale, Ph.D., as director of process engineering.

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