BioLife Solutions Completes Corporate Facilities Expansion, Build-Out of Additional cGMP Clean Room Manufacturing Suite
BOTHELL, Wash., — 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.

