FDA accepts BioCision’s ThawSTAR master file

The US Food and Drug Administration (FDA) this month accepted the Device Master File (MAF) submission for BioCision’s ThawSTAR automated cell thawing system. The ThawSTAR MAF (MAF2643) encompasses information pertaining to the specifications, materials and quality and manufacturing processes used in producing the ThawSTAR system.

“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,” says BioCision CEO Rolf 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 [current good manufacturing practice] customers, such as those in the cord blood and cell banking segments.”

The ThawSTAR system automatically thaws frozen 1.8 to 2.0 mL cryogenic vials containing cells or other biospecimens, replacing manual methods such as thawing vials in warm water baths. Measuring only 11.0 x 14.5 cm and weighing 1.2 kg with a power supply, the ThawSTAR system can be readily placed into a laminar flow hood where the rest of the cell handling workflow is performed. 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. “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,” says Ehrhardt.