BloodStor biopreservation media product platform for cord blood banking industry

Aug 31 2009

BioLife Solutions, Inc. (OTC Bulletin Board: BLFS), a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, today announced the launch of its BloodStor biopreservation media product platform. The product family includes BloodStor 55-5 for cryopreservation of umbilical cord blood stem cells, as well as other variants for peripheral blood derived stem cells. BloodStor 55-5, packaged in standard, single-use sterile vials of various fill volumes, is formulated with 55% USP grade DMSO and 5% USP grade dextran-40 in water for injection quality (WFI) water and supports a common cord blood processing protocol.

Mike Rice, BioLife's chairman and CEO, noted, "The launch of our BloodStor product family supports our mission to become the leading provider of preservation tools for cells, tissues, and organs. Specifically, our BloodStor product offering should enable BioLife to more quickly capture a larger share of the demand for preservation media products used in the rapidly growing cord blood banking industry. We're leveraging our Quality System and the capacity of our recently validated internal manufacturing facility to offer more standard and custom products to our strategic markets. We've already received orders for BloodStor 55-5 and expect to begin customer shipments by the end of September."

BioLife's manufacturing facility and quality system are compliant with 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.

All BloodStor products are tested for sterility to USP 71, endotoxin to USP 85, pH, appearance, and cell-based preservation efficacy.