BioLife Solutions and OriGen Biomedical to Offer Sterile, Pre-Filled Biologic Cell and Tissue Packaging Products to the Cell Therapy and Regenerative Medicine Markets

BOTHELL, Wash. and AUSTIN, Texas, Jan. 21 /PRNewswire-FirstCall/ --  BioLife Solutions, Inc. (OTC Bulletin Board: BLFS), a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, and OriGen Biomedical, a leading provider of biologic packaging products for research and clinical blood and cell-based therapies, today announced that the companies will introduce sterile standard and custom biologic packaging products pre-filled with BioLife's serum-free, protein-free HypoThermosol® cell and tissue storage/transport media and CryoStor™ cryopreservation media.

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Mike Rice, BioLife's chairman and CEO, noted, "The introduction of next generation biologic cell and tissue packaging products pre-filled with our sterile, GMP biopreservation media products greatly supports our mission to become the leading provider of biopreservation tools for cells, tissues, and organs.  OriGen has a broad portfolio of blood and cell storage and freezing bag products and the ability to provide custom packaging of various materials including EVA and FEP (Teflon®), along with custom and standard configurations of sterile ports, connectors, tubing, overpouches, and labeling options.  Our jointly marketed pre-filled biologic packaging products should enable clinical customers to better comply with FDA and other regulations on the validation, compatibility, manufacturing, packaging, and stability of cell-based and tissue-based regenerative medicine products."

BioLife and OriGen have entered into a non-exclusive, worldwide distribution agreement under which OriGen will purchase BioLife's HypoThermosol and CryoStor products for distribution to OriGen customers. In addition, the parties executed a contract manufacturing services agreement under which BioLife will manufacture OriGen's DMSO and DMSO/Dextran cryopreservation media products under sterile GMP conditions into various packaging options.

OriGen CEO Richard Martin remarked on forming a strategic relationship with BioLife by stating, "Our customers have been asking for our stem cell transport and freezing bags pre-filled with sterile, pre-formulated preservation media so we're very pleased to announce a partnership with BioLife to provide these enhanced products.  While the cell therapy market is still at an early stage, a growing body of customers is placing a high value on solutions that maintain a closed system from start to finish.  BioLife's biopreservation media products have been adopted by several leading cell therapy companies due to improved preservation results and the quality and regulatory footprint of the products.  We recently audited BioLife's quality systems and GMP facility and are impressed by their focus on quality, capabilities, and capacity.  We're pleased to partner with BioLife to support improved quality in cell therapy product development and commercialization by offering high quality pre-filled biologic packaging products."

Human cells, tissues, and cellular and tissue-based products (HCT/P's) are regulated in the US by the Food and Drug Administration under 21 CFR 1271.3(d)(1), and Sections 351 and 361 of the Public Health Service Act.  The European Union and several other regions outside the US have similar regulations regarding the approval, manufacturing, and distribution of cell and tissue based products.

BioLife's Bothell, Washington manufacturing facility and quality systems are certified to ISO 13485:2003 and 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, ISO 13408 for aseptic processing of healthcare products, and ISO 14644 for Clean Rooms and Associated Controlled Environments.  BioLife expects to achieve CE Mark conformity for its products during the second quarter of 2010.

BioLife and OriGen will be attending, exhibiting, and participating in panel discussions at the Phacilitate Cell & Gene Therapy conference, January 25-27, 2010, in Washington, DC.  For more information please visit http://www.phacilitate.co.uk/pages/cgtherapy/index.html.

About BioLife Solutions, Inc.:

Founded in 1998, with the initial development of its intellectual property base in 1992, 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™ 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.  US FDA Master Files are available for cross-reference. BioLife's enabling technology provides research and clinical organizations significantly extended storage stability and improved post-preservation viability and recovery of cells, tissues, and organs.  For more information please visit www.biolifesolutions.com.

About OriGen Biomedical, Inc.:

Founded in 1990, OriGen Biomedical is a privately held medical device manufacturer headquartered in Austin, Texas. OriGen engineers have more than 25 years of design experience with dozens of different specialty medical devices for cardiac care and cell culture. OriGen manufactures a range of disposables, including specialty bags for cell culture and stem cell freezing using EVA, FEP and Kapton/FEP materials. These products are extremely well suited for tissue and cell culture, stem cell expansion and long-term freezing in liquid nitrogen. OriGen's FEP products are unsurpassed for direct immersion into liquid nitrogen. Origen is ISO 13485:2003 certified, and all products have received marketing clearance from the US FDA, are registered for use in Canada, and conform to CE Mark requirements.  For more information please visit www.origen.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.

SOURCE BioLife Solutions, Inc.; OriGen Biomedical, Inc.