TrakCel has announced a partnership agreement to incorporate its needle-to-needle supply chain management platform into the Cell and Gene Therapy Catapult’s large scale cell and gene therapy manufacturing centre. The 7,200m² manufacturing centre provides a state of the art GMP facility and support infrastructure to enable collaborators to carry out the large scale manufacture of cell and gene therapies as they progress towards commercial supply.

Establishing a robust supply chain from the scheduled collection of patient samples, tracking throughout the manufacturing process and delivery back to that same patient is a complex process. As a result, it is becoming increasingly critical for manufacturers as the patient numbers involved in late stage clinical trials and future commercial supply increase. This partnership will allow Cell and Gene Therapy Catapult collaborators to plug into an established software solution that will be able to track cell therapies across the whole supply chain, completely integrated within its validated systems at the manufacturing centre and associated cryo-storage and logistics facilities.

Keith Thompson, Chief Executive Officer of the Cell and Gene Therapy Catapult, said “We are pleased to provide our partners at the manufacturing centre with complementary tracking technology, such as the TrakCel Cellular Orchestration Platform, as we work to not only offer GMP manufacturing support in Stevenage but also ease our collaborator’s access to a fully developed, high quality global supply chain.”

The TrakCel technology will link, in addition to the manufacturing centre, with Thermo Fisher Scientific’s new Fisher Bioservices CryoHubSM, being built adjacent to the manufacturing centre warehouse. The Cryohub will provide services for distribution of patient sample collection sets, cGMP cryostorage of cell and gene therapies and also cryologistics for supply of these therapies throughout the UK and beyond, with Europe’s busiest airport, Heathrow, just an hour away.

TrakCel technology will also help further establish the Stevenage Bioscience Catalyst, where these services are located, as an emerging cell and gene therapy cluster not just for the UK but globally by offering another world first in life sciences innovation.

Keith Thompson said “This integration of GMP manufacturing, cryo-storage and logistics support within a complete end to end supply chain management solution is something which has not been done before and is critical to enabling commercial supply of cell and gene therapies in the UK.”

This partnership will provide the world’s first supported GMP manufacturing base for cell and gene therapies enabling visibility across the entire manufacturing and supply process. The TrakCel platform will provide real time audit logs and chain of custody records and will reduce the implementation risks associated with disparate, paper-based systems and therefore accelerate the scale up and scale out of cell therapy processes. The project will also demonstrate flexibility and the ability to link with any other commercially available or bespoke tracking systems employed by future collaborators in this fast moving field.

The Cell and Gene Therapy Catapult specifically selected TrakCel as it has an established product installed and validated at sponsors, clinical sites, CMOs and logistic partners across North America and Europe. To minimise risks to product quality and patient safety it is essential that the supply chain is tracked and controlled both before and after the manufacturing process. The TrakCel platform has been proven to deliver this.

Ravi Nalliah, CEO of TrakCel, said “The cell therapy sector is now starting to move from considerations around clinical development to commercialisation, and multi-layered supply chains involving many more patients, individuals and organisations. Patients will rely on the sector to ensure supply chains involve the adequate transportation of valuable cellular material in the right conditions. As the most-advanced software developer for global cell and gene therapy supply chain tracking and orchestration, TrakCel is contributing its tracking capabilities to a range of international collaborations and firms. 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.”