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CERTIFICATIONS

ISO 13485:2003

CATEGORIES & HEADINGSdetails >>

Handling / Storage //

Cryopreservation Equipment

Services //

Shipping / Logistics

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BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company’s proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife’s biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. BioLife’s enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs.

Internal and independent data clearly indicate that our proprietary biopreservation media products, HypoThermosol® and CryoStor®, enable significant reduction in the levels of apoptosis and necrosis, the two mechanisms of cell death, in comparison to traditional preservation media. Biologics preserved with our products have demonstrated greatly extended shelf life and increased post-preservation cell yield, viability, and functional return. This improved preservation efficacy is made possible with reduced concentrations of cryoprotectants such as DMSO, in fully defined, serum-free and protein-free formulations.

Strategic Markets
Our products and consulting services are highly valued in five key market segments; regenerative medicine, cell and tissue banking, cord blood banking, drug discovery, and organ preservation. We estimate the worldwide demand for biopreservation media products to be at least $100 million and growing at 15-20% per year.

Manufacturing Capacity
BioLife Solutions operates two independent, multi-grade current Good Manufacturing Practices (cGMP) suites. The facilities have received ISO13485 certification, representing a comprehensive quality management system for the design and manufacturing of medical devices. The Quality Management System also adheres to 21 CFR 820 Parts 210 and 211, covering GMP for quality system regulation of aseptic production, and ISO14644 for cleanrooms and associated controlled environments. Internal audits are performed at all critical functions with a third party reviewing internal audits.

Quality & Regulatory Systems
Since the commencement of operations of our manufacturing facility in the second quarter of 2009, we have successfully passed numerous audits by current and prospective distribution partners and pharmaceutical, regenerative medicine, and contract manufacturing customers.

Customer feedback is a vital part of our continuous quality improvement process. Our Case Management System is designed to quickly respond to customer requests and track trends to improve processes and provide input to corrective and preventive actions. We combine this valuable input with our own internal audit findings to continually improve our quality environment.