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Manufacturing Vaccines: An Illustration of Using PAT Tools for Controlling the Cultivation of Bordetella pertussis

Summary: [This abstract is based on the authors' abstract.] An illustration demonstrates the operational consistency of a biopharmaceutical process. Four batch cultivations are monitored by two different process sensors. Data from both sensors were evaluated by a multivariate tool for data acquisition, resulting in two different performance models characteristic for the implementation of the Process Analytical Technology (PAT) guidance document issued by the Food and Drug Administration for the manufacture of biopharmaceuticals. By using such models, advanced knowledge-based systems can be developed to detect abnormalities at an early stage and remove the cause.

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  • Topics: Engineering
  • Keywords: Pharmaceutical industry, Biomedical, Process analysis, Calibration, Batch processes, Analytical modeling, Data processing,
  • Author: van Sprang, Eric N.M.; Ramaker, Henk-Jan; Streefland, Mattieu; van der Pol, Leo A.; Beuvery, E. Coen; Smilde, Age. K
  • Journal: Quality Engineering