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How can manufacturing reduce the risk of batch failures during scale-up from clinical to commercial production?
Posted : 03/04/2026 11:46 am
Perform thorough process characterisation and define proven acceptable ranges for critical process parameters. Scale dependent effects such as mixing, oxygen transfer, and shear should be evaluated using representative scale down models before commercialisation.
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Posted : 17/04/2026 11:46 am
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