PRESS
RELEASE
BioLife Solutions Announces FDA Master File Acceptance for CryoStor™ Pre-formulated Cryopreservation Media
BOTHELL, WA – May 8, 2008 – BioLife Solutions Inc. (OTCBB: 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 one hundred development-stage cell therapy companies have evaluated or adopted
HypoThermosol® 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 or
download the Master File Request Form .
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.