BioCision Announces FDA Master File Acceptance for ThawSTAR
News Sep 10, 2015
BioCision, LLC has announced that the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health, accepted its Device Master File (MAF) submission for the ThawSTAR automated cell thawing system.
“We have seen tremendous global interest for the ThawSTAR technology since launching this product nine months ago and believe it sets a new standard for how cells and cell-based therapies are thawed in-process and in the clinic,” said Rolf O. Ehrhardt, MD, PhD, BioCision Chief Executive Officer.
Utilizing 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.
“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 others,” continued 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.”
This FDA Master File (reference number MAF2643) encompasses information pertaining to the specifications, materials and quality and manufacturing processes used in producing the ThawSTAR automated cell thawing system.