Cell-based therapies are produced and cryopreserved under strict Good Manufacturing Practice (GMP) conditions. The final delivery, thaw and administration of these often fragile therapies is a crucial step which has to be controlled to ensure maximum therapeutic effect for the patient.
In 2014, the Cell and Gene Therapy Catapult team spoke to a number of clients and collaborators in the industry to understand the need and the required capabilities for a thawing system compliant with GMP requirements and certified as a medical device. From these conversations, it was identified that a small benchtop thawing system which could accept different packaging options (vials and bags) and meet GMP requirements, with a robust reporting architecture, would be fundamental to controlling and monitoring the final stages of release and use of cryopreserved therapies.
Once the need was confirmed, a challenge call was released to identify the best partner and UK-based company, Asymptote, were successful in their bid and began working in collaboration with the CGT Catapult team to develop the device.
The development of the thawing device fills a crucial gap in the GMP cryochain and has enabled the CGT Catapult to tap into the capabilities across the organisation from manufacturing, regulation and market access expertise.
Two different prototypes (vial and bag) have been successfully created and in early 2016 CGT Catapult and Asymptote signed an exclusive, worldwide, royalty bearing licence agreement by which CGT Catapult grants the rights of all the foreground IP generated by this collaboration to Asymptote, enabling them to commercialise the system. Once CGT Catapult had signed the licencing agreement with Asymptote, they began commercialising the technology.
“Working with the Catapult has given us a great opportunity to apply our expertise in cryobiology to the challenges of cell thawing. We’ve been able to eliminate the contamination risks and process variability inherent in water bath thawing while also providing therapy manufacturers with an immediate record of the entire process. For the industry it means much greater confidence that the dose administered to the patient is exactly what the manufacturer intended.”John Morris, Asymptote CEO