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The safety and efficacy of a biopharmaceutical drug are of the highest priority. Therefore, manufacturers have to design, implement and maintain measures to ensure that the bioprocess constantly delivers a high-quality product and patients are never at risk. The robustness of the manufacturing process has to be validated in order to bring a new biological drug to market.
Regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) demand strict requirements on process characterization and validation studies and ask for a deep process understanding. Mechanistic process models provide advantages over other methods for meeting these requirements, and they can be applied in all stages of process characterization and validation (PC/PV) from process design space development up to linkage studies.
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