Automated delivery of high-viability therapeutic cell populations following revival from cryopreservation

The project aims to develop a commercial demonstrator instrument - the ReVive Controlled Thaw device (ReVive-CT) to customers within the cell therapy sector who ship frozen product to the patient and need to ensure the highest possible viability and reproducibility of cells at the point of treatment. Combining core biological and engineering skills in order to 'pharmaceuticalise' use of cryopreserved therapeutic cells - the transition from cleanroom to clinic will be streamlined to optimise (1) ease of delivery to the patient, (2) high-viability and cell dosage (and therefore high efficacy), and (3) consistency and reproducibility of high-quality product delivered. Furthermore, it is envisaged that the system will have additional applications - eg during early-stage bioprocessing - where controlled thawing of cells from banked stocks is an important processing consideration.

Achieving the overall objective of this project - successful design and production of an automated device to thaw, clean up and dispense high-viability cells in an automated fashion - will have significant impact on (1) academic and commercial groups who use cryopreserved cells for research, (2) commercial manufacturers of cells for therapeutic use or for the production of therapeutic biologicals, and (3) above all, patients receiving cell therapies and cell-derived therapies.

ReVive-CT will have a tangible impact on patients in a number of ways. By making cell therapeutic products more reproducible, consistency of product will be significantly enhanced. This is especially important for patients who are receiving autologous products which are prone to patient-to-patient variation due to numerous factors (such as age, medical history and underlying pathology). The net effect to patients will be a greater range of cost-effective, reproducible and efficacious products.

Development of ReVive-CT is an innovative and ambitious project. There are currently no available GMP-compliant products which combine the potential to thaw cells in a controlled manner, clean up the product by removing dead cells and cellular debris, assess viability, re-formulate to the required volume/dose and administer directly to the patient. A number of patent searches have been performed, and no competing products have been identified (although some automated viability counters were identified, these were not integrated into a multi-functional GMP-compliant product like ReVive-CT). The
innovative nature of this project is further reinforced by extensive IP and know-how held by the other, industrial consortium members: ImmunoSolv has developed, and owns all rights to the Dead-Cert product range (which will be utilised to remove dead cells and debris), whilst WideBlue has extensive, proven experience in developing novel, innovative devices for the MedTech sector.

ReVive-CT comprises five distinct but integrated functions (thaw; clean; count; formulate; deliver). Additional commercial potential exists to 'de-bundle' specific ReVive-CT components into three 'stand-alone' products - each having significant
market potential. These three modular products would comprise (i) a controlled thaw device (ii) a unit with ability to clean cell populations, quantify viable cells and formulate into a desired volume, and (iii) a medical device with potential to deliver cells to the patient in defined volumes at the bedside. Each of these approaches will attract a different customer base, which ranges from R&D laboratories to transplant units.