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New container developed for the needs of cell and gene therapy (CGT) primary packaging to replace cryopreservation bags with a fracture resistant, rigid construction built for both manual use and closed-system automation.
BOTHELL, Wash., May 29, 2024 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), a leading supplier of bioproduction tools and services for the cell and gene therapy (CGT) and broader biopharma markets, today announced the introduction of the CryoCase, an addition to its CellSeal product line.
"Particulates in drug product is a growing problem that we believe can be reduced with better primary containers."
CellSeal CryoCase™ primary packaging for cell and gene therapies
Expected to be released to CGT developers in August, the CryoCase is available for demonstration at this week's ISCT event in Vancouver, Canada. Early product evaluators stated that the CryoCase's volume versatility, rigid and protective structure, and fill and retrieval port designs, allows for easy integration with their current systems generating improved throughput and streamlined procedures.
The CryoCase is the first ever cryo-compatible rigid container designed for closed-system fill and retrieval for larger volumes of fluid (<75mL). The container is transparent, enabling improved end user compliance with USP 790, USP 1790, and other international visible inspection methods, and manufactured under strict environmental and processing controls designed to limit common sources of particulates in single-use disposable manufacturing. Early user testing has shown comparable cell viability and recovery for multiple cell types compared to storage in existing bags and drop testing in a frozen state demonstrates high resistance to leaks or fractures. Initial testing indicates that the CryoCase may materially reduce or eliminate particulates inherent in cryopreservation bags.
"Particulates in reagent manufacturing and final drug product is a growing problem that we believe can be reduced with better primary containers and true, closed-system approaches to CGT manufacturing," stated Todd Berard, Chief Marketing Officer. "The CryoCase is compatible with various downstream processing systems including our Signata CT-5, and we believe it can reduce overall risks and costs involved in creating and distributing these lifesaving therapies."
CryoCase samples are now available for testing. Contact your BioLife Solutions representative for more information.
About BioLife Solutions
BioLife Solutions is a leading supplier of class-defining bioproduction tools and services for the cell and gene therapy (CGT) and broader biopharma markets. Our expertise facilitates the commercialization of new therapies by supplying solutions that maintain the health and function of biologic materials during collection, development, storage, and distribution. For more information, please visit www.biolifesolutions.com or follow BioLife on LinkedIn and X.
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