BOTHELL, Wash., Dec. 23 /PRNewswire-FirstCall/ -- BioLife Solutions, Inc. , a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, today announced that it has successfully completed audits of its quality systems and GMP production facility in Bothell, Washington by BSI Group and has been issued a certification to ISO 13485:2003, an international standard for quality systems supporting the design, development, and manufacture of medical devices.
Mike Rice, BioLife’s chairman and CEO, noted, “This achievement is a strategic quality milestone for BioLife. Our growing clinical customer base expects us to set a high bar for the production of our GMP biopreservation media products, since many customer applications include the use of our products as a combined preservative/injection delivery solution for cell-based therapies used to treat cancer, heart failure, and a host of other diseases. We’re continuing to enhance the quality footprint of our proprietary, best-in-class HypoThermosol(R) and CryoStor(TM) biopreservation media products with this certification and updates to our FDA Master Files. Furthermore, we expect to achieve CE Mark conformity for our products in 2010.”
Rice continued, “We also successfully completed quality audits of our new GMP production facility and quality systems by several strategic customers and continue to build our profile as the first choice for clinical grade preservation, transport, freezing, and injection media solutions for cell-based products. We’re pleased that a growing number of clinical customers have selected our products over commercial competitors or internal formulation of preservation media, often made using lower quality components in sub-optimal processes. We’re also very pleased to support our customers with custom packaging and custom formulations of our serum-free, protein-free, pre-formulated biopreservation media products.”
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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