Whitepaper: How controlled freezing enables scalability

In a comprehensive study the impact of ice front growth speed on scalability of freezing protein solutions has been evaluated.

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. Particularly when producing different drug products at different sensitivities, temperature setpoints it relieves the commercial bulk production.
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 growth speed had a significant impact on the control and as a result on the quality of the protein.

The new insights from the study from Single Use Support and TU Vienna pave the way towards a freezing and thawing in a controlled and scalable environment, by controlling the ice front growth speed throughout different scales, by reaching high product homogeneity during freezing and by maintaining highest protein activity.