BOTHELL, Wash., Dec. 7 BioLife Solutions, Inc. (OTC Bulletin Board: BLFS), a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, today announced that it has executed a license and custom cGMP manufacturing agreement with Centocor Research & Development, Inc. The agreement includes the production of a custom variant of BioLife's proprietary serum-free and protein-free CryoStor biopreservation media product, which is formulated with a reduced concentration of 2% DMSO.
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Mike Rice, BioLife's chairman and CEO, noted, "We are pleased with this request for a custom variant of CryoStor DLite, which will be manufactured in our Bothell cGMP production facility, which offers robust quality systems, manufacturing capacity, and flexibility in providing customer-specific biopreservation media products critical to the successful commercialization of new life-saving cellular therapy products."
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BioLife's manufacturing facility and quality system adhere to 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.
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® 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.
Media Relations: Investor Relations:Len Hall Matt ClawsonAllen & Caron Inc Allen & Caron Inc(949) 474-4300 (949) [email protected] [email protected]
SOURCE BioLife Solutions, Inc.
