Whitepaper: How Controlled & Scalable Freezing Becomes Reality

Controlled Freezing & Thawing of Biopharmaceuticals

Being able to control the freezing behavior of bulk drug substance is the ultimate goal in Biopharma 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. This simplifies commercial bulk production, particularly when manufacturing different drug substances with various product characteristics.

As one of the most essential parameters in terms of achieving control over freezing & thawing bulk, the freezing rate has been considered and evaluated in different tests. Using the ice front growth speed as a leverage had a significant impact on controllability and, as a result, on protein quality.