A consortium including TrakCel, the Cell and Gene Therapy Catapult, Rexgenero Ltd and Fisher Bioservices (part of Thermo Fisher Scientific) has secured funding of £1.4 million from Innovate UK, the UK’s innovation agency, to lead an industrial research project.
The project will focus on and design a cost effective commercial manufacturing strategy for Rexgenero’s novel autologous cell therapy REX-001. It has been shown to stimulate the growth of new blood vessels to restore blood supply to the limb, alleviate symptoms and improve quality of life of critical limb ischemia patients.
In addition to the funding from Innovate UK, the consortium partners will invest a further GBP £4 million.
The research project, which is expected to run for 21 months, will include process redesign, automation and scale-out for commercial manufacture.
TrakCel will be developing a needle-to-needle supply chain software management platform for the consortium. This will enable the consortium to establish a robust supply chain from the scheduled collection of patient samples, tracking throughout the manufacturing process and delivery back to that same patient.
The software will also provide real-time audit logs, chain-of-custody records, reduce the implementation risks associated with disparate, paper-based systems and therefore accelerate the scale up and scale out of REX-001.
Ravi Nalliah, CEO, TrakCel, said: “By adding TrakCel’s capabilities to international consortia, such as this specific UK-based consortium concentrating on the REX-001 project, this enables a more effective commercialisation strategy for cell therapies to reach patients more effectively.”