BioLife Solutions is located in Bothell, Washington, on a high-tech campus that has its roots as a dairy farm.
We design, manufacture, and market proprietary and generic cGMP biopreservation media products for cells, tissues, and organs. We also perform contract research and offer consulting to optimize customer specific biopreservation protocols and processes. And for our direct, distributor, and contract customers, we perform custom formulation, fill, and finish services.
Internal and independent data from our 300+ strong customer base clearly illustrate how our proprietary cGMP biopreservation media products, HypoThermosol and CryoStor, enable significant reduction in the levels of apoptosis and necrosis, the two mechanisms of hypothermic-induced cell death, in comparison to traditional biopreservation media formulations.
A variety of cells, tissues, and organs stored or frozen with our biopreservation media products have demonstrated greatly extended shelf life and improved post-preservation cell yield, viability, and functional return. This improved biopreservation efficacy is made possible with reduced concentrations of cryoprotectants such as DMSO, in fully defined, serum-free and protein-free formulations.
Our products and consulting services are highly valued in three strategic market segments: regenerative medicine, biobanking, and drug discovery. Axis Research Mind estimates the global market value for cryopreservation equipment used in the stem cells industry to be worth $2.2 billion by 2015, representing a compound annual growth rate of about 24%. Freezers represent more than half of the cryopreservation equipment market value, with biopreservation reagents accounting for close to 20% of the total market. Accordingly, BioLife’s addressable market is estimated at nearly $450 million in 2015.
In the first quarter of 2009, we completed the construction and validation of a state of the art GMP clean room manufacturing suite. In addition to regular production of HypoThermosol, CryoStor, and BloodStor biopreservation media products, we also perform custom formulation, fill, and finish services for direct, distributor, and contract customers.
Quality & Regulatory Systems
Our cGMP manufacturing facility has been qualified according to ISO 14644, Clean Rooms and Associated Controlled Environments as called out in Volume 4, EU GMP Guidelines, Annex 1: Manufacture of Sterile Medicinal Products, with requalification of the facility every six months. The facility was designed based upon the output of risk analysis as per ISO 14971, Application of Risk Management to Medical Devices.
Our Quality Management System is certified to ISO 13485:2003, Quality Management Systems – Requirements for Regulatory Purposes. Regularly scheduled surveillance audits by our certifying authority ensure continued adherence to this standard. Under the standard, we must demonstrate not only the dedication of senior management to cGMP standards, but also our commitment to provide quality product using the best available materials and methods.
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.
To assist customers with their regulatory marketing applications, Master Files for BioLife products are on file with the FDA. To request a cross reference to our Master Files, please complete our convenient request form.