Study Reveals Best Practices for Time/Temperature-Sensitive Biologics

BioLife Solutions and Brooks Life Sciences Partner on Study of Best Practices for Shipping and Storing Time- and Temperature-Sensitive Biologic Materials.

BioLife Solutions, Inc. (BLFS) is a developer, manufacturer and marketer of proprietary clinical-grade cell and tissue hypothermic storage and cryopreservation-freeze media and a related cloud-hosted biologistics cold chain management app for smart shippers.

It recently collaborated with Brooks Automation, a worldwide provider of automation and cryogenic equipment for life sciences, on a shipping and storage study to support best distribution practices for time- and temperature-sensitive biologic materials.

Both companies serve the growing regenerative medicine industry and are focused on delivering solutions that enable commercialization of cell-based products, including CAR T-Cells and other cell types, targeting cancer, heart disease, diabetes, stroke, movement disorders and loss.

BioLife's CryoStor and HypoThermosol® cell storage and shipping media are embedded in more than 220 customer validations and clinical trials of cellular therapies. Brooks Life Sciences supplies devices, tools, services and software for long-term biologic sample storage and management.

The study was presented as a poster at the International Society for Cellular Therapy (ISCT) 2016 Annual Meeting in Singapore.  An expanded white paper on the study is also available.

In the study, current practices for cell freezing using a serum-containing home-brew freeze media and shipping using a common foam dry ice container were compared to best practices of using serum-free, clinical-grade CryoStor freeze media and the evo Smart Shipper. Cells were frozen, shipped from BioLife to Brooks, transferred to liquid nitrogen storage for 45 days, then shipped back from Brooks to BioLife and assessed for viability and functional recovery. Significant improvement in total cell survival (viability) and faster regrowth (recovery) post-thaw were observed in the cells frozen in CryoStor and shipped in the evo Smart Shipper.

Specific findings included the following:

• Jurkat T-cells frozen in traditional 95/5% cryomedia and shipped in an EPS container experienced a significant decline in viability immediately post thaw and a delayed return to function 48 hr post-thaw.

• The combination of CryoStor CS5 and the CRYO evo smart shipper afforded superior protection from cryopreservation and transportation stress with no measurable decline in structural and functional viability as a result of freezing, thawing and two cross-country transit events.

• The CRYO evo smart shipper and biologistex™ cloud-based shipment application allow real-time status, tracking and event alarms throughout the entire shipping process, permitting enhanced tracking and knowledge of any environmental excursions as they happen.

• The design of the CRYO evo smart shipper prevented payload warming from dry ice sublimation and maintained the Jurkat T-cells within the desired temperature range throughout transit.

• The BioStore III Cryo storage system safely stored the Jurkat T-cells below -190°C, prevented unauthorized access and monitored all activities to ensure no samples ever crossed Tg (-135°C). With LIMS connectivity, reports and alarms, storage conditions and inventory was available at all times.

Kevin O'Donnell, Vice President of Cold Chain Standards, Practices, and Compliance at BioLife says, "The evo Smart Shipper is designed to protect precious biologic payloads during shipments, by maintaining consistent temperature of the entire payload throughout transit, and while being subjected to challenging ambient temperature environments. This is critical for high-value and potentially life-saving cellular therapeutics."

John Fink, Director, Product Marketing for Cryogenic Automation at Brooks, added, "This study further reinforces the need for enhanced and vigilant temperature monitoring of samples during transit and storage.”

BioLife Solutions estimates the addressable market for small-format shipping containers and data monitoring systems at $500 million. Brooks estimates the addressable market for sample management at $1.3 billion.

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