BOTHELL, Wash., Aug. 31 /PRNewswire-FirstCall/ -- BioLife Solutions, Inc. (OTC Bulletin Board: BLFS), a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, today announced the launch of its BloodStor biopreservation media product platform. The product family includes BloodStor 55-5 for cryopreservation of umbilical cord blood stem cells, as well as other variants for peripheral blood derived stem cells. BloodStor 55-5, packaged in standard, single-use sterile vials of various fill volumes, is formulated with 55% USP grade DMSO and 5% USP grade dextran-40 in water for injection quality (WFI) water and supports a common cord blood processing protocol.
Mike Rice, BioLife's chairman and CEO, noted, "The launch of our BloodStor product family supports our mission to become the leading provider of preservation tools for cells, tissues, and organs. Specifically, our BloodStor product offering should enable BioLife to more quickly capture a larger share of the demand for preservation media products used in the rapidly growing cord blood banking industry. We're leveraging our Quality System and the capacity of our recently validated internal manufacturing facility to offer more standard and custom products to our strategic markets. We've already received orders for BloodStor 55-5 and expect to begin customer shipments by the end of September."
BioLife's manufacturing facility and quality system are compliant with 21 CFR part 820 - Quality System Regulation for Good Manufacturing Practices (GMP) of medical devices, 21 CFR parts 210 and 211 covering GMP for Aseptic Production, Volume 4, EU Guidelines, Annex 1 for the Manufacture of Sterile Medicinal Products, and ISO14644 for Clean Rooms and Associated Controlled Environments. The Company expects to achieve the ISO13485 medical device quality management systems certification by the end of 2009.
All BloodStor products are tested for sterility to USP 71, endotoxin to USP 85, pH, appearance, and cell-based preservation efficacy.
BioLife Solutions will be presenting and exhibiting at the AABB annual meeting & TXPO, October 25-27, 2009 in New Orleans, Louisiana. For more information please visit www.aabb.org.
About BioLife Solutions
BioLife Solutions develops, manufactures, and markets patented hypothermic storage/transport and cryopreservation media products for cells, tissues, and organs. The Company's proprietary HypoThermosol((R)) and CryoStor((TM)) platform of biopreservation media products are marketed to academic research institutions, hospitals, and commercial companies involved in cell therapy, tissue engineering, cord blood banking, drug discovery, and toxicology testing. BioLife's GMP products are serum-free and protein-free, fully defined, and pre-formulated to reduce preservation-induced, delayed-onset cell damage and death. Comprehensive small animal intravenous safety studies have been completed on HypoThermosol and CryoStor, and both products are supported by US FDA Master Files. BioLife's enabling technology provides research and clinical organizations significantly enhanced post-preservation cell and tissue viability and function. For more information please visit www.biolifesolutions.com.
This news release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements include any statements that relate to the intent, belief, plans or expectations of the Company or its management, or that are not a statement of historical fact. Any forward-looking statements in this news release are based on current expectations and beliefs and are subject to numerous risks and uncertainties that could cause actual results to differ materially. Some of the specific factors that could cause BioLife Solutions' actual results to differ materially are discussed in the Company's recent filings with the Securities and Exchange Commission. BioLife Solutions disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
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|SOURCE BioLife Solutions, Inc.|
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