Quality System and Facility Support Increased Capacity, Cost Reductions, Custom Packaging, Regulatory Filings
BOTHELL, Wash., June 9 /PRNewswire-FirstCall/ -- BioLife Solutions, Inc. , a leading biopreservation tools provider, today announced that it has completed the construction and validation of its internal GMP manufacturing facility and has released the first production lot of its biopreservation media products made in Bothell for commercial sales.
In the third quarter of 2008, the Company announced that it was transitioning from using a contract manufacturer to internal production in order to reduce production costs and enable custom packaging and formulation offerings to the growing market for biopreservation media products.
BioLife’s Quality System and nearly 6,000-square-foot GMP production facility incorporates a uni-directional workflow design that was finalized with the input of several clean room consultants and members of BioLife’s Quality, Scientific and Regulatory Advisory Board. The facility consists of ISO14644 classified airlocks and rooms for product formulation, filling, final inspection and cold storage, as well as other mixed and dedicated use space including research and development and quality control laboratories and order fulfillment space. All critical systems are supported by auto-switched generator power.
Mike Rice, BioLife’s chairman and CEO, noted, “We’re very pleased to have met our cost, schedule, and quality goals for this construction project. We now have the capacity to produce up to 12,000 liters of HypoThermosol and CryoStor biopreservation media annually, and have the ability to increase this significantly by investing in additional automation equipment. Over the coming quarters, we expect to realize volume driven cost reductions and will leverage our internal production capabilities to offer custom packaging and product variants to meet customer demand for our best-in-class biopreservation media products.”
About BioLife Solutions, Inc.:
BioLife Solutions develops and markets patented hypothermic storage/transport and cryopreservation media products for cells, tissues, and organs. The Company’s proprietary HypoThermosol(R) and CryoStor(TM) platform of biopreservation media products are marketed to academic research institutions, hospitals, and commercial companies involved in cell therapy, tissue engineering, cord blood banking, drug discovery, and toxicology testing. BioLife’s cGMP products are serum-free and protein-free, fully defined, and formulated to reduce preservation-induced, delayed-onset cell damage and death. BioLife’s enabling technology provides research and clinical organizations significant improvement in post-preservation cell and tissue viability and function. For more information please visit www.biolifesolutions.com.
This news release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements include any statements that relate to the intent, belief, plans or expectations of the Company or its management, or that are not a statement of historical fact. Any forward-looking statements in this news release are based on current expectations and beliefs and are subject to numerous risks and uncertainties that could cause actual results to differ materially. Some of the specific factors that could cause BioLife Solutions’ actual results to differ materially are discussed in the Company’s recent filings with the Securities and Exchange Commission. BioLife Solutions disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
CONTACT: Media Relations, Len Hall, len@allencaron.com, or Investor
Relations, Matt Clawson, matt@allencaron.com, both of Allen & Caron Inc,
+1-949-474-4300, for BioLife Solutions, Inc.
Web site: http://www.biolifesolutions.com/
