Cardiff, UK, September 11, 2018 – TrakCel, the cell and gene therapy supply chain tracking and orchestration system software developer, today announces it has been engaged to build a custom-configured system for Medeor Therapeutics, a clinical-stage biotechnology company dedicated to the discovery, development and commercialization of personalized cellular immunotherapies engineered to reprogram the immune system in order to improve outcomes in organ transplant recipients.
The supply chain system will be used in the clinical development and commercialization of Medeor’s MDR-10X product candidates for immune tolerance in living donor kidney transplant recipients. Medeor’s lead product candidate, MDR-101, is in a pivotal Phase 3 trial for genetically-matched living donor kidney transplant recipients. The company has a pipeline of product candidates to support various other indications.
The TrakCel-built system will seek to ensure that each patient receiving a transplanted organ will also receive therapies manufactured from the blood and bone marrow cells of the specific organ donor. The system will also help to ensure that apheresis material collected from the organ donor will be aligned with the supply chain logistical requirements of multiple US contract manufacturing facilities.
The supply chain system will support a full pipeline of Medeor products, including the ongoing phase 3 clinical trial of MDR-101. It will be specifically designed to:
- automate and standardize information flow and tasks across supply chain stakeholders
- manage the complex timing of events for donors, recipients, manufacturers, couriers and clinicians
- improve efficiencies and minimize supply chain risk and failures, including verifying the chain of identity and chain of custody, ensuring that the transplant recipient receives the right drug every time.
“TrakCel is now supporting a variety of companies and organizations developing a full range of autologous and allogeneic advanced therapies from the cell, gene and personalized cancer vaccine fields. Medeor is now close to a very exclusive peer group of companies with a commercialized cell therapy product. In addition, the company has a robust development pipeline and has considerable funding to achieve its goals,” said Ravi Nalliah, CEO of TrakCel. “Developing cell therapies in the underserved organ transplant field will be facilitated by our cellular supply chain tracking and orchestration platform, with high levels of flexibility and scalability.”
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.