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 (CLI) patients.
The research project will include process redesign, automation and scale-out for commercial manufacture. The project is expected to run for 21 months.
In addition to the £1.4 million funding from Innovate UK, the consortium partners will invest a further £0.4 million.
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.
It 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.
“The commercialisation phase for cell therapies requires multi-layered supply chains involving many patients, individuals and organisations. This is why consortiums and organisations focused on commercialising cell therapies require an advanced software developer for supply chain tracking and orchestration,” said Ravi Nalliah, CEO, TrakCel.
“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.”