Controlling the freezing behavior of bulk drug substance opens doors to process reproducibility and consistent quality of the final drug product by maintaining uniform conditions during freezing and thawing, and for storage and shipment in the frozen state. This not only simplifies the commercial bulk production, particularly when manufacturing different drug substances at different sensitivities and temperature setpoints, but also enables scalability in cryogenic applications. The ice front growth speed had a significant effect on controllability and, as a result, on the protein quality.
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