BioLife Solutions Announces Custom cGMP Manufacturing & License Agreement
Variant of CryoStor DLite® Biopreservation Media Used in Cell Therapy Product Development
PRNewswire-FirstCall
BOTHELL, Wash.

BioLife Solutions, Inc. (BULLETIN BOARD: BLFS) , a leading developer, manufacturer, and marketer of biopreservation tools for cells, tissues, and organs, today announced that it has executed a license and custom cGMP manufacturing agreement with Centocor Research & Development, Inc. The agreement includes the production of a custom variant of BioLife's proprietary serum-free and protein-free CryoStor biopreservation media product, which is formulated with a reduced concentration of 2% DMSO.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090814/BIOLIFELOGO)

Mike Rice, BioLife's chairman and CEO, noted, "We are pleased with this request for a custom variant of CryoStor DLite, which will be manufactured in our Bothell cGMP production facility, which offers robust quality systems, manufacturing capacity, and flexibility in providing customer-specific biopreservation media products critical to the successful commercialization of new life-saving cellular therapy products."

BioLife's manufacturing facility and quality system adhere to 21 CFR part 820 - Quality System Regulation for Good Manufacturing Practices (GMP) of medical devices, 21 CFR parts 210 and 211 covering GMP for Aseptic Production, Volume 4, EU Guidelines, Annex 1 for the Manufacture of Sterile Medicinal Products, and ISO14644 for Clean Rooms and Associated Controlled Environments. The Company expects to achieve the ISO13485 medical device quality management systems certification by the end of 2009.

About BioLife Solutions

BioLife Solutions develops, manufactures, and markets patented hypothermic storage/transport and cryopreservation media products for cells, tissues, and organs. The Company's proprietary HypoThermosol® and CryoStor™ platform of biopreservation media products are marketed to academic research institutions, hospitals, and commercial companies involved in cell therapy, tissue engineering, cord blood banking, drug discovery, and toxicology testing. BioLife's GMP products are serum-free and protein-free, fully defined, and pre-formulated to reduce preservation-induced, delayed-onset cell damage and death. Comprehensive small animal intravenous safety studies have been completed on HypoThermosol and CryoStor, and both products are supported by US FDA Master Files. BioLife's enabling technology provides research and clinical organizations significantly enhanced post-preservation cell and tissue viability and function. For more information please visit www.biolifesolutions.com.

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.

  Media Relations:                Investor Relations:
  Len Hall                        Matt Clawson
  Allen & Caron Inc               Allen & Caron Inc
  (949) 474-4300                  (949) 474-4300
  len@allencaron.com              matt@allencaron.com

First Call Analyst:
FCMN Contact:

Photo: http://www.newscom.com/cgi-bin/prnh/20090814/BIOLIFELOGO
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SOURCE: BioLife Solutions, Inc.

CONTACT: Media Relations, Len Hall, len@allencaron.com, or Investor
Relations, Matt Clawson, matt@allencaron.com, both of Allen & Caron Inc,
+1-949-474-4300, for 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

Mastering
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Cell Performance