Case study applied to bioprocess industrialization

This activity explores the impacts of scaling up from the laboratory to the manufacturing site, identifying associated gaps and risks. It introduces the GARAMP method to analyze these gaps and propose appropriate corrective actions.

This activity describes the conditions and criteria required for a successful technology transfer of a monoclonal antibody manufacturing process. It emphasizes the verification of remediation plans, the preparation of the production site, and the monitoring of the first technical batches.

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