BOTHELL, Wash., May 8 /PRNewswire-FirstCall/ -- BioLife Solutions Inc. (OTC Bulletin Board: BLFS), a leading developer and marketer of proprietary hypothermic storage and cryopreservation media products for cells, tissues, and organs, today announced that its Master File for CryoStor cryopreservation media has been accepted by the United States Food and Drug Administration (FDA).
BioLife Chairman and Chief Executive Mike Rice commented: "We believe that the FDA Master File for CryoStor will provide clinical researchers and commercial partners easier access to our best-in-class cryopreservation media and facilitate faster product development of cell and tissue based products. Although classified as excipient materials, our sterile products are manufactured under medical device quality regulations and are made from only USP or the highest available grade components.
"We're optimistic that having an FDA Master File will also help accelerate product adoption in our key clinical markets, including cell therapy and cord blood and cell banking," Rice continued. "Our value proposition centers on providing the highest quality off-the-shelf and ready-to-use biopreservation media products with what is now the best regulatory footprint in the industry. Referencing our Master File should take some of the regulatory burden off our customers, so they can focus more time and resources on product development and clinical therapies."
More than 100 development-stage cell therapy companies have evaluated
or adopted HypoThermosol(R) and/or CryoStor in the production of novel
cell-based products targeting a multitude of diseases and disorders such as
cancer, heart failure, vision loss, and neurologic disorders. In addition,
TriMark Publications, LLC, a global leader in market research and
intelligence for biotechnology, healthcare and life sciences, forecasts the
global market for stem cell products and services to $104 billion by 2012.
PA Consulting Group, a
|SOURCE BioLife Solutions Inc.|
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