BOTHELL, Wash., April 27, 2015 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), a leading 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"), today announced that the United States Food and Drug Administration has confirmed acceptance of the Company's Master Files for its Cell Thawing Media products. 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. Product and Master File information is listed below and customers may request a cross reference to the Master Files for the products using the following link: BioLife Solutions Master File Cross Reference Request Form.
Cell Thawing Media (10% Dextran in 0.9% NaCl): 250ml Bag; Part number: 980203
FDA Master File number 16441
Cell Thawing Media (10% Dextran in 5% Dextrose): 250ml Bag; Part number: 981203
FDA Master File number 16442
Mike Rice, BioLife Solutions President & CEO, commented on the submission of Master Files for the Company's Cell Thawing Media products by stating, "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. 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."
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.
About BioLife Solutions
BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company's proprietary HypoThermosol® and CryoStor® biopreservation media products are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's proprietary products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. This enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.
This press release contains forward-looking statements, including, but not limited to, statements concerning the company's anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, projected financial results, new products, and third party projections regarding the future market for regenerative medicine and cold chain packaging and instrumentation services. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of products; uncertainty regarding third party market projections; market volatility; competition; litigation; reliance upon SAVSU for completing the development and manufacturing of biologistex CCM's products; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
Media & Investor Relations
Daphne Taylor
Senior Vice President, Chief Financial Officer
(425) 402-1400
dtaylor@biolifesolutions.com
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SOURCE BioLife Solutions Inc.