The following is a release from BioLife Solutions:
Bothell-based BioLife Solutions, Inc. (NASDAQ: BLFS) announced on April 27 that the United States Food and Drug Administration has confirmed acceptance of the company’s Master Files for its Cell Thawing Media products.
Biolife Solutions is a developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues (“BioLife” or the “Company”).
“We are pleased to have completed this process, which helps our customers incorporate our products into their standard operating procedures for clinical administration of previously frozen cells to patients,” said BioLife Solutions President and CEO Mike Rice. “Customer interest and orders for our Cell Thawing Media products are increasing and we are appropriately focused on driving continued adoption of these products. Our manufacturing team responded quickly to this opportunity to help our existing and new customers to minimize disruption in administering therapeutic cells to patients in need.”
While not an endorsement nor approval of BioLife’s products for a specific indication, FDA acceptance of the Master Files streamlines the qualification process for BioLife customers to use these products in clinical applications such as stem cell transplants. An FDA Master File provides key information about the quality of components, materials and manufacturing processes used in producing medical devices and drugs, including related products such as biopreservation media used to preserve and store biologic materials including cells, tissues and organs.
Launched in February 2015, BioLife’s GMP-manufactured low molecular weight (LMD) Dextran solutions are used for thawing cells after cryopreservation storage. The company launched these new products in response to inquiries from numerous customers and clinicians who have been subjected to an extended worldwide shortage of dextran solutions that are used off-label to transition frozen cells from frozen storage.
BioLife’s HypoThermosol and CryoStor are also supported by FDA Master Files, which have been cross-referenced numerous times for use in regenerative medicine clinical trials.
