BOTHELL, Wash., Oct. 14, 2014 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues ("BioLife" or the "Company"), today provided an update on use of the Company's HypoThermosol storage/shipping media and CryoStor cryopreservation freeze media by Progenitor Cell Therapy, LLC (PCT), a wholly owned subsidiary of NeoStem, Inc., (NASDAQ: NBS) a leader in the emerging cellular therapy field.
PCT is an internationally recognized contract development and manufacturing organization (CDMO) focused on providing exceptional service, quality and value to its regenerative medicine clients, which include an expanding range of development stage organizations, Fortune 500 biotechnology, pharmaceutical and medical product companies, as well as leading academic research institutions. PCT operates two state-of-the-art, accredited and certified U.S. facilities, one in Allendale, New Jersey and the other in Mountain View, California.
Robert A. Preti, PhD, President & Chief Scientific Officer at PCT, commented on the use of BioLife products by stating, "Two critical commercialization challenges for novel cell and tissue-based products stem from limited shelf life and poor quality following preservation. Over the last several years we have evaluated many custom formulations and commercial preservation media products for storage, shipping, freezing, and administering cell-based biologics in clinical applications. The biopreservation efficacy of BioLife's clinical grade HypoThermosol and CryoStor is very impressive. There is a high degree of awareness of these products in the field and we use BioLife products in several of our current cell therapy development projects, including some of NeoStem's clinical product candidates along with many programs for mutual customers of BioLife and PCT."
A 2013 visiongain Translational Regenerative Medicine market research report forecasts that the regenerative medicine market comprised of cell and gene therapies and tissue-engineered products will grow to more than $23 billion by 2024. BioLife estimates that the Company's biopreservation media products are now incorporated into the collection, storage, shipping, freezing, and/or patient administration processes of at least 130 customer clinical trials or novel cell-based regenerative medicine products and therapies.
Mike Rice, BioLife President & CEO, stated, "The use of HypoThermosol and CryoStor at PCT is further validation of the value our proprietary biopreservation media products provide to the high growth regenerative medicine market. PCT is a very high quality contract development and manufacturing services provider and we recognize the scrutiny with which they evaluated our products, leading to adoption and use in multiple projects, both internal and for mutual customers. We look forward to continuing and strengthening our relationship with PCT."
About Progenitor Cell Therapy
Progenitor Cell Therapy (PCT) is a leading contract development and manufacturing organization in the cellular therapy industry. For over 15 years, PCT has provided pre-clinical and clinical cGMP development and manufacturing services to more than 100 clients, advancing regenerative medicine product candidates from the development stage all the way through to human testing. For more information please visit www.pctcelltherapy.com
About NeoStem
NeoStem is a leader in the emerging cellular therapy industry, pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The business includes the development of novel proprietary cell therapy products as well as a revenue-generating contract development and manufacturing service business. This combination has created an organization with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation. For more information please visit www.neostem.com.
About BioLife Solutions
BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company's proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. BioLife's enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.
This press release contains forward-looking statements, including, but not limited to, statements concerning the company's anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, new products, and third party projections regarding the future market for regenerative medicine and cold chain packaging and instrumentation services. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of products; uncertainty regarding third party market projections; market volatility; competition; litigation; reliance upon SAVSU for completing the development and manufacturing of biologistex CCM's products; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
Media & Investor Relations
Daphne Taylor
Senior Vice President, Chief Financial Officer
(425) 402-1400
dtaylor@biolifesolutions.com
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.
Streamline workflows and safeguard therapies
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GMP-COMPATIBLE
Our biopreservation media and storage solutions are engineered to maintain cell integrity and functionality. With GMP-compatible, validated formulations, we help you reduce variability and improve post-thaw recovery, ensuring robust and reproducible outcomes.
CELL VIABILITY
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CELL VIABILITY
With deep industry experience, regulatory support, and a commitment to innovation, BioLife Solutions is dedicated to supporting bioprocess engineers in overcoming complex manufacturing challenges. Whether optimizing cryopreservation protocols or ensuring the seamless transition from lab to clinic, we are dedicated to your success.
QUALITY & COMPLIANCE
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QUALITY & COMPLIANCE
Enhance efficiency and consistency in your cell processing workflow with our closed-system tools for fluid management and cell processing that are automation ready. Reduce manual handling errors, improve throughput, and achieve higher standards of quality and compliance as you scale towards commercialization.
REGULATORY SUPPORT
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REGULATORY SUPPORT
BioLife Solutions delivers specialized tools and expertise to help bioprocess engineers streamline and strengthen biopreservation processes across the cell therapy workflow. From selecting the right biopreservation media to minimizing cell loss during freezing, storage, and transports, our solutions are designed to improve consistency, reduce risk, and support a successful transition from development to clinical application.
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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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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.
