BioLife Solutions Customer Kite Pharma Receives FDA Approval for Yescarta™ (Axicabtagene Ciloleucel) CAR T-Cell Therapy
Each Yescarta Dose is Frozen in Proprietary CryoStor® Freeze Media to Maintain CAR T-Cell Viability and Enable Worldwide Distribution

BOTHELL, Wash., Oct. 19, 2017 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media ("BioLife" or the "Company"), today announced that its customer Kite Pharma, Inc., a wholly-owned subsidiary of Gilead Sciences, has received US FDA approval for Yescarta, the first CAR T-cell therapy for treatment of adult patients with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy. As announced in a July 2016 press release, BioLife executed a long-term agreement to supply its proprietary CryoStor cell freeze media to Kite Pharma. Each manufactured dose of Yescarta is frozen in CryoStor to maintain CAR T-cell viability and enable worldwide distribution.

Biolife Solutions Inc. logo. (PRNewsFoto/BIOLIFE SOLUTIONS INC.)

Mike Rice, BioLife President & CEO, commented, "This is a great day for cancer patients. Kite Pharma is on the forefront of bringing potential cures for several different cancers to the market. We are proud to be a critical supplier to Kite Pharma and look forward to supporting their additional CAR T-cell clinical trials by supplying CryoStor for use in their manufacturing and distribution processes."

For more information please visit:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581216.htm

About BioLife Solutions

Our proprietary HypoThermosol® and CryoStor® platform of biopreservation media products are highly valued in the regenerative medicine, biobanking and drug discovery markets. These are serum-free, protein-free, fully defined, and formulated to reduce preservation-induced cell damage and death.  Our enabling, embeddable technologies 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.

Cautions Regarding Forward Looking Statements

Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are 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, commercial manufacturing of our customers' products, and projected financial results. 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) 686-6002
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.

Work with experts who understand your biopreservation challenges

Notch-Right-25px
Notch-Bottom-25px

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.

Notch-Left-25px
Notch-Bottom-25px

STORE

CellSeal®
CryoCase

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

Notch-Right-25px
Notch-Bottom-25px

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.

Insights

May 21, 2025

Designing the Ideal Cryostorage Container for CGT

April 18, 2025

The Cell Summit ’25: A Must-Attend Event for Innovators in Cell & Gene Therapy

March 27, 2025

Optimizing Biopreservation Strategies for Apheresis-Derived Cells in Immunotherapeutic Applications

February 19, 2025

How to prepare early for regulatory submissions from IND to BLA

Preserve, protect and expand cell performance

Mastering
Biopreservation

Ensure Regulatory Submission Readiness

Automate & Close
CGT Processes

Protect & Expand
Cell Performance