BioLife Solutions Products Now Used in More than 50 Clinical Trial-Stage Cellular Therapies
Company's Novel Biopreservation Technology Recognized as Leading Choice For Commercialization In Emerging Field of Regenerative Medicine
PR Newswire
BOTHELL, Wash.

BOTHELL, Wash., Oct. 29, 2012 /PRNewswire/ -- BioLife Solutions, Inc. (OTCBB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced the Company's novel biopreservation technology is being used in more than 50 clinical trial-stage cellular therapies, making it the leading choice in the emerging, high growth field of regenerative medicine. Management believes that the Company holds the number one supplier position among companies offering pre-formulated cell and tissue storage and freeze media used in clinical trial stage cellular therapies to treat the leading causes of death and disability such as cancer, heart disease, stroke, and joint/movement disorders.

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BioLife Chief Executive Officer Mike Rice indicated that the Company's revenue from its growing regenerative medicine customer base, along with its selective targeting of contract manufacturing customers, should generate cash and profits in the interim until some regenerative medicine customers gain approval and adoption. At that point, profitable growth should accelerate in a step-wise fashion.

Rice commented: "We've built a very strong franchise for HypoThermosol® and CryoStor® in developing commercial cell and tissue-based products and therapies.  It's very satisfying to see the biopreservation efficacy and best-in-class quality of our products recognized by more companies and hospital-based transplant centers using pre-formulated storage, shipping, and freeze media products. Since 2006, we've consistently converted these customers from using 'home-brew' formulations to our cGMP, protein-free, serum-free biopreservation media products."

Based on customers cross-referencing BioLife's FDA Master Files for its HypoThermosol and CryoStor products for use in their regulatory filings, customer orders, and other customer communication, BioLife management believes the Company's potential annual revenue from the regenerative medicine market could reach $50 million over the next several years, should its customers be successful in obtaining regulatory approval for their cell-based products currently in clinical trials.

A recent visiongain report "Translational Regenerative Medicine: Market Prospects 2012-2022" values the regenerative medicine market at $1.4 billion in 2012, and growing to $10 billion by 2020.  BioLife's addressable portion of the market is the demand for reagents used to store, ship and freeze source material and manufactured doses of cell-based products and therapies.

Rice continued, "The challenges in commercializing cell-based products have been exposed since the first few approvals were granted.  Product shelf life and post-preservation viability are critical to good clinical outcomes and commercial success, and we're pleased to see the field recognize the reduction in overall manufacturing costs that can be enabled through the use of our products.  Bioprocessing and biopreservation are executed along a continuum, with cumulative positive and negative yield and cost impact, depending on the quality and performance of the tools and reagents used along the way.  HypoThermosol and CryoStor are recognized as critical reagents and we're looking forward to seeing our customers' products in the market and available to clinicians and patients in the years to come."

BioLife Solutions is co-sponsoring the Stem Cells on the Mesa conference October 29 – 30, in La Jolla, CA.  The Company plans to file its 10-Q quarterly report for the third quarter of 2012 on November 13.

About BioLife Solutions

BioLife Solutions develops, manufactures and markets patented hypothermic storage and cryopreservation solutions for cells and tissues.  The Company's proprietary HypoThermosol® and CryoStor® platform of solutions are marketed to academic and commercial organizations involved in cell therapy, tissue engineering, cord blood banking, drug discovery, and toxicology testing. BioLife's products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced, delayed-onset cell damage and death.  BioLife's enabling technology provides academic and clinical researchers significant improvements in post-thaw cell, tissue, and organ viability and function.  For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.

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. 

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SOURCE BioLife Solutions, Inc.

We believe the promise of cell and gene therapies starts with the integrity of a single cell

Advancing the future of cell and gene therapy

The human body can heal itself. Cell and gene therapies are designed to augment the patient’s ability to fight disease but only if the living cells behind those therapies remain viable and functional throughout the production processes. At BioLife Solutions, our mission is to protect the integrity of cells and provide trusted tools, services, and expertise that can enable our customers to advance the development and delivery of cell and gene therapies. We believe the future of cell and gene therapies hinges on the integrity of every single cell and we are here to protect that promise.

We understand the technical demands of bioprocessing in this field, and our advanced biopreservation expertise, cell culture optimization products, innovative storage systems, and closed-system manufacturing solutions are designed to enhance process efficiency, maintain cellular viability, and ensure reproducibility at every stage. Whether scaling up from R&D, navigating clinical trials or optimizing cryopreservation protocols for commercial production, we provide the tools and experience to streamline your workflow and safeguard your therapies.

Work with experts who understand your biopreservation challenges

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Collaborative and comprehensive CDMO support

At BioLife Solutions, we partner with leading contract development and manufacturing organizations (CDMOs) to enhance their biopreservation and cell processing capabilities. By providing advanced tools, regulatory support, and process optimization strategies, we empower CDMOs to better serve therapy developers, ensuring quality, consistency, and scalability in cell therapy manufacturing.

Regulatory
readiness

Navigating the complex regulatory landscape of cell and gene therapy requires a proactive approach. BioLife Solutions offers experienced regulatory support to help prepare your biopreservation and cell processing methods to meet global standards. From IND and BLA submissions to compliance with GMP, FDA, and EMA guidelines, our solutions help streamline approval pathways.

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Alleviate CGT container challenges like fracture risk, bag burping or high rates of particulates

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Data-driven
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Stay ahead with our comprehensive Evidence Library, a curated collection of scientific publications, white papers, and case studies demonstrating the efficacy of BioLife Solutions’ technologies. Access peer-reviewed research, real-world application data, and expert insights to support your bioprocessing and regulatory strategies.

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Preserve, protect and expand cell performance

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Ensure Regulatory Submission Readiness

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Cell Performance