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news.BioLife Solutions, a Bothell, Washington-based developer, manufacturer and marketer of biopreservation tools for cells, tissues and organs, and OriGen Biomedical, an Austin, Texas-based provider of biologic packaging products for research and clinical blood and cell-based therapies, 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.
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In addition, the parties have 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.
Mike Rice, chairman and CEO of BioLife, said: “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.”
Richard Martin, CEO of OriGen, said: “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.”