Design Space Identification and Visualization for Continuous Pharmaceutical Manufacturing

Pharmaceutics
Samir Diab, Dimitrios I Gerogiorgis

Abstract

Progress in continuous flow chemistry over the past two decades has facilitated significant developments in the flow synthesis of a wide variety of Active Pharmaceutical Ingredients (APIs), the foundation of Continuous Pharmaceutical Manufacturing (CPM), which has gained interest for its potential to reduce material usage, energy and costs and the ability to access novel processing windows that would be otherwise hazardous if operated via traditional batch techniques. Design space investigation of manufacturing processes is a useful task in elucidating attainable regions of process performance and product quality attributes that can allow insight into process design and optimization prior to costly experimental campaigns and pilot plant studies. This study discusses recent demonstrations from the literature on design space investigation and visualization for continuous API production and highlights attainable regions of recoveries, material efficiencies, flowsheet complexity and cost components for upstream (reaction + separation) via modeling, simulation and nonlinear optimization, providing insight into optimal CPM operation.

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Citations

Sep 27, 2020·Pharmaceutics·Ossi Korhonen
Jun 21, 2020·Pharmaceutics·Moritz von StoschMatthew Sanders

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Methods Mentioned

BETA
acylations

Software Mentioned

CapEx

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