Within the manufacturing world of solid dosage forms, many applications have been implemented in recent years using advanced analytical technologies and digital tools for supporting an enhanced control strategy. This presentation will discuss a pilot project related to sterile manufacturing with the objective to implement a control system using real time elements and making use of predictive multivariate models for process monitoring of different aseptic unit operations.
The presentation will elaborate on how to take the first steps towards Real Time Release Testing for a drug product biotech process introducing new analytical technologies covering physicochemical assays as well as rapid microbiological assessments. Furthermore the difference of multivariate statistical process control applied to a DP process in comparison with a drug substance process will be illustrated. The goal of this initiative is primarily to simplify the release process and reduce the overall release lead times. An outlook on how to extend this concept to a drug substance process will be given.
Head of Advanced Analytical Technologies,
F. Hoffmann-La Roche Ltd.
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