BioCision and Celgene Cellular Therapeutics Join to Develop Cell Thawing Technology

San Rafael, Calif.-based BioCision LLC, which makes technology for the improvement of biological sample handling and standardization, is starting a collaboration with Celgene Cellular Therapeutics (CCT) (a subsidiary of Celgene Corporation) to accelerate the development of a cell thawing solution based on BioCision’s proprietary Thawstar technology. Thawstar will be adapted for the 6 mL injectable vial that CCT has chosen to store PDA-002, a cryopreserved, allogeneic cell therapy currently in clinical development to treat diabetic foot ulcers in patients with peripheral arterial disease.

Conventional thawing methods, such as swirling vials in warm water baths or rolling vials between hands, can result in variable cell viabilities and can increase contamination concerns. BioCision’s Thawstar system uses a patent-pending adaptive sensing technology that incorporates algorithms to deliver a consistent and reproducible thaw profile and endpoint to each vial, thus providing a standardized thawing process, eliminating variability that could have a detrimental effect on the safety and efficacy of the cell therapy, and providing a significant reduction in cell handling risk in a clinical setting.

“As more cell therapies reach late stage clinical trials and commercialization, the need to standardize and de-risk cell handling, including thawing, is becoming critical,” said Rolf O. Ehrhardt, M.D., Ph.D., CEO of BioCision, said. “The Thawstar system has been demonstrated to significantly improve cell viability and recovery in comparison to conventional methods, and may ultimately enhance the consistency of therapeutic outcomes.”

The new Thawstar automated cell thawing system that will be developed as a result of this collaboration is an expansion of BioCision’s technology platform and will be made available commercially. BioCision is also developing other vial formats to address the needs of the larger cell therapy market.