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Tags: Critical quality attribute

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  1. Tracking raw material flow through a continuous direct compression line. Part II of II: Predicting dynamic changes in quality attributes of tablets due to disturbances in raw material properties using an independent residence time distribution model

    09 Jun 2023 | Contributor(s):: Peterwitz, M, Buchgeister, SMeier, R, Schembecker, G

    Continuous manufacturing of pharmaceuticals promises many advantages regarding economics and quality. However, tracing deviating material in such processes is much more challenging than in batch processes due to axial back-mixing. The literature has proven the traceability of disturbances in the...

  2. Faster to First-time-in-Human: Prediction of the liquid solid ratio for continuous wet granulation

    09 Jun 2023 | Contributor(s):: Junnila, A, Wikstrom, HMegarry, A, Gholami, A, Papathanasiou, F, Blomberg, A, Ketolainen, J, Tajarobi, P

    In early development, when active pharmaceutical ingredient (API) is in short supply, it would be beneficial to reduce the number of experiments by predicting a suitable L/S ratio before starting the product development. The aim of the study was to decrease development time and the amount of API...