BioLife Solutions Introduces the CellSeal CryoCase™ at International Society for Cell & Gene Therapies (ISCT) Conference in Vancouver

Rhea-AI Summary

BioLife Solutions (NASDAQ: BLFS) introduced the CryoCase, a new addition to its CellSeal product line at the ISCT Conference in Vancouver. The CryoCase is designed for cell and gene therapy (CGT) primary packaging, aiming to replace cryopreservation bags with a fracture-resistant, rigid construction. It supports both manual and automated, closed-system use.

Available for demonstration at the ISCT event and expected to release to CGT developers in August, the CryoCase offers volume versatility, structural rigidity, and fill/retrieval port designs. It complies with USP 790 and USP 1790 standards and has shown high resistance to leaks and fractures during drop tests.

Early user tests indicated CryoCase may reduce particulates in single-use disposable manufacturing, potentially improving cell viability and recovery. Compatible with BioLife's Signata CT-5 system, CryoCase is expected to lower risks and costs in CGT manufacturing.

Positive

• Introduction of CryoCase targeting a growing CGT market.
• Designed to reduce particulates in drug products, improving quality.
• Fracture-resistant and rigid construction enhancing safety and reliability.
• Supports both manual and automated closed-system use.
• Complies with USP 790 and USP 1790 standards for visual inspection.
• High resistance to leaks and fractures, as shown in drop tests.
• Potentially reduces risks and costs in CGT manufacturing.
• Early user tests show improved cell viability and recovery.

Negative

• New product introduction without sales data or revenue forecasts.
• No detailed financial impact or cost-benefit analysis provided.
• Potential initial costs and required system integrations for users.
• Dependence on successful adoption by CGT developers.

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."

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.

Media & Investor Relations

At the Company
Troy Wichterman
Chief Financial Officer
(425) 402-1400
twichterman@biolifesolutions.com

Investors
LHA Investor Relations
Jody Cain
(310) 691-7100
jcain@lhai.com

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SOURCE BioLife Solutions, Inc.

FAQ

What is BioLife Solutions' new CryoCase?

The CryoCase is a fracture-resistant, rigid container for CGT primary packaging, designed to replace cryopreservation bags.

When will the CryoCase be available?

The CryoCase is expected to be released to CGT developers in August 2024.

What are the benefits of the CryoCase?

The CryoCase offers volume versatility, structural rigidity, and is designed to reduce particulates, improving cell viability and recovery.

Is the CryoCase compatible with existing systems?

Yes, the CryoCase is compatible with various downstream processing systems, including BioLife's Signata CT-5.

What standards does the CryoCase comply with?

The CryoCase complies with USP 790 and USP 1790 standards for visual inspection.