BOTHELL, Wash., July 23, 2012 /PRNewswire/ -- BioLife Solutions, Inc. (OTCBB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract media manufacturer, today announced that it has completed the expansion of its corporate office and operations workspace and also the build-out of its second current Good Manufacturing Practice (cGMP) clean room suite.
Chief Executive Officer Mike Rice said, "We are currently in a hiring and expansion phase, thanks to the growth of our customer base and increased demand for our products. Our new corporate facilities and expanded operations and support areas will enable us to increase production of our platform HypoThermosol® and CryoStor® biopreservation media products, and also to stage and store raw materials and finished biopreservation media products manufactured under contract. Our second, independent, multi-classed cGMP clean room suite is currently in the validation phase and we look forward to bringing this on line early in the fourth quarter of 2012."
Certified to ISO 13485:2003 since 2009, the Company's manufacturing facility and quality systems 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.
Rice continued, "Our investments in additional manufacturing capacity and new team members will enable us to meet current and future demand for our proprietary products, as we are optimistic that some number of our customers in the regenerative medicine market will gain marketing and regulatory approval for their cell and tissue-based products, which incorporate HypoThermosol and/or CryoStor as critical storage, shipping, freezing, and infusion reagents. Post-approval, product demand from any single customer in this segment will increase exponentially compared to orders received during the pre-clinical and clinical trial phases of development. We're also actively seeking new contract manufacturing opportunities to leverage our capacity and expertise."
Once fully validated and fully staffed, management forecasts total annual production capacity at over 120,000 liters.
About BioLife Solutions
BioLife Solutions develops, manufactures and markets patented hypothermic storage and cryopreservation freeze media products for cells and tissues. The Company's proprietary HypoThermosol® and CryoStor® platform of solutions are marketed to academic and commercial organizations involved in cell therapy, tissue engineering, cord blood banking, drug discovery, and toxicology testing. BioLife's products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced, delayed-onset cell damage and death. BioLife's enabling technology provides academic and clinical researchers significant improvements in post-thaw cell, tissue, and organ viability and function. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.
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.