Thawstar

The ThawStar automated cell thawing system by BioCision LLC.

BioCision LLC, San Rafael, Calif, recently announced that FDA’s Center for Devices and Radiological Health has accepted the company’s device master file submission for the company’s ThawStar automated cell thawing system.

“We have seen tremendous global interest for the ThawStar technology since launching this product nine months ago, and we believe it sets a new standard for how cells and cell-based therapies are thawed in-process and in the clinic,” says Rolf O. Ehrhardt, MD, PhD, BioCision CEO.

Utilizing BioCision’s patent-pending Star sensing technology, the ThawStar thawing instrument employs multiple detection mechanisms and algorithms to determine vial temperature, phase change initiation, and thaw completion, customizing the thaw for each vial containing frozen cellular material. The system’s intuitive, hands-free operation eliminates the guesswork and subjectivity of determining the thawing end point, setting a new bar in thawing reproducibility and making it a necessary component in processes that rely on standardized procedures.

Ehrhardt

Rolf O. Ehrhardt, MD, PhD, BioCision.

“Although currently designated for research and investigational use only, we have seen rapid adoption of our ThawStar units into cell therapy clinical trials for indications such as diabetes, organ transplantation, heart disease, and other applications,” says Ehrhardt. “Having this FDA master file enables these customers to more easily integrate the product into their workflows and will also provide an added level of quality assurance to our other cGMP customers, such as those in the cord blood and cell banking segments.”

The FDA master file (reference number MAF2643) encompasses information pertaining to the specifications, materials, quality systems, and manufacturing processes used in producing the ThawStar automated cell thawing system. Customers wishing to reference the master file are encouraged to contact BioCision.

For more information, visit BioCision.