BioCision Expands Automated Cell Thawing Technology Platform
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BioCision, LLC, announced that it is expanding its award-winning ThawSTAR® automated cell thawing technology platform to accommodate rapidly developing industries such as cell therapy which are bringing products to the clinic in a variety of formats.
The company is commercially releasing two thawing systems for 1.5 mL cryogenic vials and 6 mL AT-Closed Vials® from Aseptic Technologies, S.A., and accelerating the development of an automated platform to thaw cryopreservation bags commonly used to store and deliver larger volume cell-based therapeutics.
The growth is being driven by an increasing awareness from cell therapy manufacturers and clinicians that potentially irreplaceable personalized therapies must be processed and handled with utmost care and precision at every step in order to deliver a robust and standardized product to patients. Cellular therapy involves the administration of living cells to patients to target and replace damaged cells to treat various diseases, and the successful long-term viability of these cells is largely dependent on proper thawing techniques. Several of the most promising cell types, such as induced pluripotent stem cells (IPSC), chimeric antigen receptor T- cells (CAR-T) and “natural killer” (NK) cells, also appear to be highly sensitive to the effects of cryopreservation and subsequent recovery. 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.
“The industry has rapidly adopted our ThawSTAR automated system for 2.0 mL cryogenic vials, both for general research use and for incorporation into in-process manufacturing and clinical trials,” said Rolf O. Ehrhardt, MD, PhD, BioCision CEO. “This expansion builds on that foundation and enables an immediate broader use of our technology. 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.”
“Within the cell therapy community, BioCision has emerged as the company to go to for cold chain and temperature management expertise,” said Ohad Karnieli, PhD, Chair of the Process and Product Development Committee, International Society for Cell Therapy (ISCT). “Their ability to rapidly adapt the ThawSTAR thawing technology to a variety of cell types and delivery formats is of great value.”
The proprietary ThawSTAR thawing system utilizes an adaptive, load-sensing technology that senses the initial starting temperature and phase change initiation, and customizes the thaw for each vial, ensuring consistent and reproducible endpoints. Vials can be inserted directly from liquid nitrogen storage (below -150 degrees Celsius), or dry ice or ultra-low freezer storage (-80 degrees Celsius).
The ThawSTAR suite of products will be on display at the Phacilitate Cell and Gene Therapy World 2016 conference, booth #226, January 25-27, 2016, at the Grand Hyatt Hotel in Washington, DC.