(11f) An Integrated Approach to Modelling, Data, and Control for Pharmaceutical Manufacturing

Authors: 
Braatz, R. D., Massachusetts Institute of Technology
An integrated Quality-by-Design approach for pharmaceutical manufacturing is described. Continuous manufacturing is an approach that brings process research and development into closer alignment and execution with manufacturing, by significantly reducing the amount of scale up needed to go from laboratory scale to production scale. Dynamic process and plant models are used for integration across different value streams, from a seamless connection from raw materials through drug substance and drug product. The streamlined process development workflow incorporates best practices from the relevant ICH guidelines [1-4], including the selection of control strategies for each critical quality attribute, and the effective use of modular plant-wide simulation. The main concepts are illustrated for small-molecule pharmaceutical pilot plants and bench-scale biologic drug manufacturing platforms. Additional challenges associated with biologic drugs are discussed. Aided with in-line process analytical technology, automated plant-wide control systems are designed and implemented to satisfy specifications on the critical quality attributes. The presentation draws from Quality by Design strategies that were developed and applied in the pharmaceutical industry from before the ICH guidelines were published [e.g., 5-7], up to recent advances [8-22].

References

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