A consortium comprising itself, the Cell and Gene Therapy (CGT) 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.
Cardiff, UK, January 23, 2018 – TrakCel, the industry-leading software developer for cell and gene therapy supply chain tracking and orchestration, announces today that the consortium comprising itself, the Cell and Gene Therapy (CGT) 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 (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 commercializing 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.”
TrakCel is the market leading designer, developer and deliverer of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel’s software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining needle-to-needle compliance and traceability.
TrakCel is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey. It aims to employ over 100 people by end of 2019, following a number of senior appointments in 2016 and 2017.
About Cell and Gene Therapy (CGT) Catapult
The Cell and Gene Therapy Catapult was established as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 300 employees focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies.
About Rexgeno Ltd
Rexgenero is a leading regenerative medicine company and developer of advanced cell-based therapeutics for the treatment of serious diseases that are poorly treated with existing therapies. We are conducting clinical trials with our cellular therapies with the intention of obtaining marketing authorization in Europe, the United States and other markets.
About Fisher Bioservices
Fisher BioServices is the industry leader in the management of critical biological materials to support the advancement of cell therapies, GMP biologics, and population-based public health research. We provide customized, end-to-end chain of custody solutions for our large pharmaceutical customers and partners in academia and government, ensuring the integrity of their valued material.
About Innovate UK
Innovate UK is the UK’s innovation agency. We help UK businesses to grow through innovation. The government’s vision is for the UK to be a global hub for innovation by 2035. Our mission in achieving that is to help companies to grow through their development and commercialisation of new products, processes and services, supported by an outstanding innovation ecosystem that is agile, inclusive and easy to navigate.
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Article by TrakCel Marketing Team - 18 Jan 2018