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.
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."
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.
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