The California, US-based technology developer has launched new versions of its ThawStar system that are designed to thaw cell therapies preserved in 1.5mL cryogenic vials and 6mL AT-Closed vials developed by Belgian firm Aseptic Technologies S.A.
The developmental bag-scale thawing system is designed to handle larger volume cell therapies, which is an increasing area of demand for manufacturers with trial and commercial stage products according to Biocision CEO, Rolf Ehrhardt.
“Providing a translational thawing platform that accommodates small- and large-volume closed system formats allows our customers to adopt it early in the research and development phase and have confidence in knowing that it can be seamlessly incorporated into commercial manufacturing, and point of care.”
Thawing is a hot topic for cell therapy developers. Most biopharmaceutical products are sensitive to temperature changes, but personalized cell therapies are particularly susceptible.
As a result cell therapies are usually frozen at the manufacturing facility before being shipped to the clinic for administration back to the patient.
But protecting these sensitive and usually irreplaceable treatments is not enough according to Biocision, which says induced pluripotent stem cells (IPSC), chimeric antigen receptor T- cells (CAR-T) and “natural killer” (NK) cells can also be damaged by the thawing process.
“The common method of thawing cryopreserved cells and cell-based therapeutics involves sequentially placing frozen vials or bags into a warm water bath; a method fraught with challenges that leaves the cells and therapies at risk of contamination and potentially jeopardizes drug efficacy and safety.”
Biocision's system is designed to eliminate water bath thawing using technology that senses the initial starting temperature and phase change initiation and customizes the thaw for each vial.