BOTHELL, Wash., Dec. 12, 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 media manufacturer, today announced that its customer TiGenix NV (Euronext Brussels: TIG) has completed a phase I clinical safety trial of its expanded adipose-derived stem cell platform incorporating BioLife's cGMP HypoThermosol cell/tissue storage/shipping medium.
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The clinical trial, titled "Phase I Clinical Trial in Healthy Volunteers to Evaluate the Feasibility and Safety of the Intralymphatic Administration Technique of Expanded Allogeneic Adipose-derived Stem Cells (eASCs)," assessed the safety, tolerability and feasibility of a potential cell-based therapy TiGenix is developing for a number of autoimmune disorders including rheumatoid arthritis.
Eduardo Bravo, TiGenix CEO, remarked on the selection of HypoThermosol as a combination shipping medium and vehicle solution for TiGenix's stem cell technology, "HypoThermosol allows us to increase the stability profile of our clinical cell-based products and considerably extends their shelf-life. Increased shelf-life of cell therapy products will be key in future commercial distribution."
Mike Rice, BioLife Solutions Chief Executive Officer, said, "We want to congratulate TiGenix on this important milestone. They join a growing list of regenerative medicine companies that have adopted our best in class biopreservation media products in the development of their clinical cell and tissue based therapies. We're very pleased to support their clinical product development."
About TiGenix
TiGenix NV (Euronext Brussels: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect®, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit http://www.tigenix.com.
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.
Streamline workflows and safeguard therapies
GMP-COMPATIBLE
Precision
biopreservation
for
maximum
viability
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
Best
practices
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processing
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
Scalable
manufacturing
and
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optimization
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
Your
partner
in
bioprocess
optimization
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.
Work with experts who understand your biopreservation challenges
Connect with
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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.
STORE
CellSeal®
CryoCase
Alleviate CGT container challenges like fracture risk, bag burping or high rates of particulates
Data-driven
decision making
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.
