Cryopreservation Archives - BioProcess InternationalBioProcess International

Dry To Die: Freezing Can Replace Spray Drying for Bulk Intermediates

Valuable bulk biopharmaceutical intermediates, such as bacterial or yeast cells for microbial fermentation or materials produced during a biomanufacturing process, often are transported to and from different manufacturing sites. During that transfer, maintaining product quality while minimizing degradation in desired properties is of utmost importance. It requires carefully controlled and reliable cold-chain logistics, which in turn rely on the equally carefully controlled process steps of freezing and thawing. Spray drying is a widely used method for preserving microbial cells. However,…

Going Big in Cold-Chain Management: Anticipating Challenges and Finding Solutions for Large Volumes

by Marion Monstier, Sebastien Chaussin and Katy McLaughlin

Bulk drug substances (BDS) often require frozen storage to preserve the integrity of biological material. Cold-chain management is particularly important given recent trends toward increasing globalization and decentralization and diversifying modalities. A secure cold chain is essential for maintaining a product’s critical quality attributes (CQAs) — such as drug product stability, integrity, and purity — and to prevent costly product losses. Scaling Up the Cold Chain Frozen storage at commercial scale presents its own challenges; facilities must be able to…

Cryopreserving Hematopoietic Stem Cells — Part 2: Methods, Materials, and Operations

by Brian Gazaille, with Erik Woods

Bone marrow (BM) remains a critical source of hematopoietic progenitors used in stem-cell transplantation. Currently, however, it is obtained almost exclusively from living donors. That approach limits what quantities of cells can be extracted during an aspiration procedure, in turn reducing the number of opportunities available for treating blood-cancer patients. In BPI’s November 2022 eBook on cryopreservation, I presented part of my conversation with Erik Woods (cofounder, chief science officer, and executive vice president of Ossium Health) about ways to…

eBook: Cryopreservation — Special Considerations for Cell Therapies

by Brian Gazaille, with Erik Woods

Freezing is an established approach to maintaining bulk drug substances/products for several biopharmaceutical modalities. Regardless of product type, a cryopreservation process requires extensive testing, monitoring, and control of freezing and thawing conditions. However, because living cells are significantly larger and more complex than monoclonal antibodies (MAbs) and other protein-based biologics, cell therapies raise distinctive concerns for cryopreservation processes. In this eBook, BPI’s managing editor speaks with Erik Wood (cofounder, chief science officer, and senior vice president of Ossium Health) to…

Cold Chain Excellence: Getting Control Over Freezing of Biologics

by Daniel Tischler

HOW CONTROLLED FREEZING ENABLES SCALABILITY: Controlling the freezing behavior of drug substance is the ultimate goal in pharmaceutical manufacturing. It opens doors to process reproducibility, consistent quality of the final drug product by maintaining uniform conditions for the biopharmaceuticals during freezing and consequently for frozen storage and shipment. As one of the most essential parameters to achieve control over freezing & thawing bulk, the freezing rate has been considered and evaluated in different tests. The leverage of the ice front…

Corning X-WASH System: DMSO Reduction of Cryopreserved Human Mesenchymal Stem Cells

by Hilary Sherman

Cryopreservation is a necessary part of workflows for both autologous and allogeneic therapies. The ability to cryopreserve cells for cell therapy increases the range of administration, shelf life, and time for safety testing. Cryoprotectants such as dimethyl sulphoxide (DMSO) often are added to freezing media to increase post-thaw cell survival. However, DMSO itself can be cytotoxic, so reducing its final concentration can be necessary. Below, I demonstrate how the Corning X-WASH system can reduce the amount of DMSO used in…

Freeze Cycle Testing of
Fluoropolymer Bottles

by Eric Isberg

Frozen storage of bulk drug substances (BDS), including bioprocess solutions, vaccines, blood components, and other delicate process fluids is common in the bioprocess industry. Vessels used to store those fluids must be capable of withstanding long-term storage in extremely cold temperatures (e.g., –85 °C or –196 °C), sometimes for very long time periods. They also must also maintain integrity after repeated thawing and subsequent refreeze. The study below was performed to characterize performance of fluoropolymer bottles with standard and two-piece…

Contractor Perspectives: Best Practices for Transfer, Handling, Testing, and Storage of Cell Banks

by S. Anne Montgomery, Scott Wheelwright and H. Fai Poon

For comments about how contract development and manufacturing organizations (CDMOs) manage their cell-banking quality assurance (QA) practices. I contacted long-time member of BPI’s Editorial Advisory Board Scott M. Wheelwright, PhD, for his perspectives. Wheelwright brings many years of experience to this discussion, with insights into the evolution of technologies and practices extending back to the early launch of the biopharmaceutical industry. Currently, he provides consulting support for companies with manufacturing and sourcing in China and other Asian countries. He also…

Single-Use Systems for Storing and Shipping Frozen Drug Materials

by Derek Pendlebury

Using presterilized, single-use freeze–thaw systems instead of traditional freeze–thaw platforms that include stainless-steel tanks and bottles can help biomanufacturers manage the quality of their drug substances. Single-use assemblies reduce the risk of cross-contamination, simplify dispensing, and decrease the number of manual interventions during freezing, thawing, handling, and shipping. However, implementing a freeze–thaw process requires careful testing of the physical and thermal properties of single-use systems and related aseptic connectors as well as assessment of drug-substance quality and stability. Such evaluation…

Cryopreserved Leukapheresis Materials Help Alleviate Donor Sourcing Issues

by Brad Taylor and Dominic Clarke

Reliable access to high-quality starting material is a primary challenge in cell therapy manufacturing. Freshly isolated leukopak starting materials depend on donor availability and are vulnerable to cell losses from scheduling changes and other unforeseen circumstances. Flexibility often is required for cell therapy manufacturing. Therefore, relying solely on freshly isolated starting material is impractical, particularly when cell therapy logistics involve global shipping and distribution. Donor sourcing is among the most critical factors shaping cell and gene therapy (CGT) supply chains.…