BioLife Solutions announces biologic packaging products pre-filled with GMP biopreservation media

Jan 21 2010

BioLife Solutions, Inc. (OTC Bulletin Board: BLFS), a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, and OriGen Biomedical, a leading provider of biologic packaging products for research and clinical blood and cell-based therapies, today announced that the companies will introduce sterile standard and custom biologic packaging products pre-filled with BioLife's serum-free, protein-free HypoThermosol® cell and tissue storage/transport media and CryoStor™ cryopreservation media.

Mike Rice, BioLife's chairman and CEO, noted, "The introduction of next generation biologic cell and tissue packaging products pre-filled with our sterile, GMP biopreservation media products greatly supports our mission to become the leading provider of biopreservation tools for cells, tissues, and organs.  OriGen has a broad portfolio of blood and cell storage and freezing bag products and the ability to provide custom packaging of various materials including EVA and FEP (Teflon®), along with custom and standard configurations of sterile ports, connectors, tubing, overpouches, and labeling options.  Our jointly marketed pre-filled biologic packaging products should enable clinical customers to better comply with FDA and other regulations on the validation, compatibility, manufacturing, packaging, and stability of cell-based and tissue-based regenerative medicine products."

BioLife and OriGen have entered into a non-exclusive, worldwide distribution agreement under which OriGen will purchase BioLife's HypoThermosol and CryoStor products for distribution to OriGen customers. In addition, the parties executed a contract manufacturing services agreement under which BioLife will manufacture OriGen's DMSO and DMSO/Dextran cryopreservation media products under sterile GMP conditions into various packaging options.

OriGen CEO Richard Martin remarked on forming a strategic relationship with BioLife by stating, "Our customers have been asking for our stem cell transport and freezing bags pre-filled with sterile, pre-formulated preservation media so we're very pleased to announce a partnership with BioLife to provide these enhanced products.  While the cell therapy market is still at an early stage, a growing body of customers is placing a high value on solutions that maintain a closed system from start to finish.  BioLife's biopreservation media products have been adopted by several leading cell therapy companies due to improved preservation results and the quality and regulatory footprint of the products.  We recently audited BioLife's quality systems and GMP facility and are impressed by their focus on quality, capabilities, and capacity.  We're pleased to partner with BioLife to support improved quality in cell therapy product development and commercialization by offering high quality pre-filled biologic packaging products."

Human cells, tissues, and cellular and tissue-based products (HCT/P's) are regulated in the US by the Food and Drug Administration under 21 CFR 1271.3(d)(1), and Sections 351 and 361 of the Public Health Service Act.  The European Union and several other regions outside the US have similar regulations regarding the approval, manufacturing, and distribution of cell and tissue based products.

BioLife's Bothell, Washington manufacturing facility and quality systems are certified to ISO 13485:2003 and 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.  BioLife expects to achieve CE Mark conformity for its products during the second quarter of 2010.

BioLife and OriGen will be attending, exhibiting, and participating in panel discussions at the Phacilitate Cell & Gene Therapy conference, January 25-27, 2010, in Washington, DC.  For more information please visit http://www.phacilitate.co.uk/pages/cgtherapy/index.html.