Continuous Drug Substance Manufacture

The objective of this training is to introduce a typical workflow for continuous drug substance manufacturing process modelling in gPROMS FormulatedProducts. Through this workshop, the user will learn how to develop a digital twin for synthetic continuous manufacturing to predict process performance and product quality. The exercise is based on a case study depicting a process for continuous manufacturing of ibuprofen, which is based on an organic synthesis pathway using a CSTR, two plug flow reactors (PFRs) in series, followed by a liquid-liquid extractor (LLE) for final separation.

The main workshop activities will include:

• Open, explore and simulate a pre-configured flowsheet,
• Configure a continuous drug substance manufacturing process model,
• Explore the effect of disturbance on the configured system,
• Use Global System Analysis to explore the sensitivity of the mass flow rates of reagents and separation solvent,
• Optimise API recovery considering constraints in solvent to feed ratio.