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BioLife Solutions Announces FDA Master File Acceptance for CryoStor(TM) Pre-formulated Cryopreservation Media
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 global consulting firm with expertise in life
sciences and healthcare, estimates the worldwide market for media to
preserve cells, tissues, and organs for research and clinical applications
will grow from $200 million in 2007 to nearly $350 million by 2011.
Rice added: “We have a growing body of internal and external data
clearly illustrating that our novel biopreservation media formulations
extend shelf- life and improve post-preservation viability and function of
numerous biologic source materials as well as manufactured cell and tissue
products and therapies. With this data and our FDA Master File, we are
striving to raise the regulatory standards for biopreservation media
products and are committed, through our proprietary products, to enabling
our customers’ successful development and commercialization of new cell and
tissue-based products and therapies.”
About the CryoStor FDA Master File:
The FDA Master File for CryoStor provides specific quality information
and specifications for the components used to manufacture CryoStor, the
cGMP quality and manufacturing system, and the release criteria for the
product. Traditional cryopreservation media are typically mixed in small
batches on- site in a clinical laboratory using variable quality components
and often under conditions that prove challenging for maintaining the
integrity of the formulation. CryoStor requires no mixing of components or
other on-site manipulation of the product by the clinician.
To request a cross reference to the Master File for CryoStor please
contact the Company.
About BioLife Solutions:
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 preservation media products are marketed to academic research
institutions, clinical care provider organizations, and commercial
companies involved in cell therapy, tissue engineering, cord blood banking,
drug discovery, and toxicology testing. BioLife 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 and viability and function. For more
information please visit http://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.
Media Relations: Investor Relations:
Len Hall Dan Matsui
Allen & Caron Inc. Allen & Caron Inc.
(949) 474-4300 (949) 474-4300
SOURCE BioLife Solutions Inc.
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