BOTHELL, Wash., Sept. 15, 2016 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers ("BioLife" or the "Company"), today announced that its clinical grade CryoStor freeze media has been embedded into the manufacturing process for HepaStem, a cell-based treatment developed by Promethera Biosciences, targeting several metabolic liver disorders such as hemophilia and large clinical indications including acute or chronic liver failure (ACLF), fibrosis and nonalcoholic steatohepatitis (NASH).
Promethera Biosciences' technology platform is based on a newly discovered cell type, isolated from normal human adult liver tissue: Heterologous Human Adult Liver-derived Progenitor Cells (HHALPC).
Patrick Stragier, Vice President of Operations at Promethera, commented on their adoption of CryoStor by stating, "BioLife's clinical grade cell freeze media has been validated by our team and shown to enable high cell recovery and viability following the manufacturing process, providing at least two years of frozen storage of HepaStem. The use of CryoStor will enable global distribution of this potentially lifesaving cellular therapy."
Mike Rice, BioLife President & CEO, remarked, "We are very pleased to support Promethera in their mission to develop effective cell-based therapies for liver disorders. Our CryoStor freeze media is broadly adopted by the drug discovery and regenerative medicine markets to protect various liver-derived cells during cryopreservation, which enables long term storage and worldwide distribution."
CryoStor and HypoThermosol®, BioLife's cell and tissue storage and shipping media, are now incorporated into more than 220 customer pre-clinical validations and clinical trials of cell-based therapies targeting blood cancers, solid tumors, vision loss, heart disease, stroke, and movement disorders.
About Promethera Biosciences
Promethera Biosciences is a clinical stage biopharmaceutical company and the global leader in cell therapy and regenerative medicine for the treatment of inborn and acquired liver diseases with no effective therapeutic cure. Promethera uses allogeneic progenitor cells, stem cells and mature hepatocytes that are harvested and purified from non-transplantable, healthy human livers (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC and Heterologous Human Liver Cells, HHLivC). These technologies have resulted in the development of three different cell products, HepaStem and H2Stem (progenitor/stem cells) and Heparesc® (mature hepatocytes). Promethera specializes in the development of therapeutic options for the treatment of a broad variety of liver diseases. These range from orphan indications, such as rare inborn metabolic diseases including urea cycle disorders (UCD) or inherited diseases such as a1at deficiency (α1-antitrypsin) and hemophilia to large indications such as acute on chronic liver failure (ACLF), fibrosis and nonalcoholic steatohepatitis (NASH).
Promethera Biosciences is a spin-off of the Walloon Region-based Université catholique de Louvain (UCL) and was founded in 2009 by Prof. Dr. Etienne Sokal and Sopartec, the tech transfer office (TTO) of UCL. Promethera is headquartered in Mont-Saint-Guibert, Belgium with a U.S. based GMP compliant manufacturing facility in Durham, NC, US. For more information please visit www.promethera.com.
About BioLife Solutions
BioLife Solutions develops, manufactures and markets biopreservation media products and smart shipping containers connected to a cloud hosted cold chain management app to improve the quality of delivery logistics for cells, tissues, and organs. 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.
The biologistex cloud based cold chain management service is an integrated logistics and tracking and trace web app used by shippers of time and temperature sensitive biologic materials. The evo Smart Shipper is a state of the art precision thermal shipping container with embedded payload monitoring, GPS location tracking, and cellular communication electronics that transmit critical shipment information to the cloud. This SaaS app enables users to monitor high value shipments during transit and configure actionable alerts for downstream recipients for location, approaching destination, delivery, package open, and remaining shelf life or stability via the patent pending StableAlert™ countdown timer. 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 new products, the company's anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, market adoption of biologistex, commercial manufacturing of our customers' products, potential proceeds from the credit facility, and projected financial results, cash flow and liquidity, including the potential for reaching positive cash flow from operations next year. 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; 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
Roderick de Greef
Chief Financial Officer
(425) 686-6003
rdegreef@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.
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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.
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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.
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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.
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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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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.
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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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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.
