Substrates adoption methodology (SAM) to achieve “Fast, Flexible, Future (F3)” pharmaceutical production processes

Ravendra Singh, Raquel Rozada-Sanchez, Tim Wrate, frans Muller, Krist Gernaey, Rafiqul Gani, John Woodley

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Abstract

There is a significant cost associated with process development of a portfolio of pharmaceutical products, few of which will reach the market. Continuous processing will increase the “chemical space” which can increase development efficiency. For example one, particularly attractive option is to develop manufacturing processes based on modular continuous systems; a flexible generic continuous modular plant which can be adapted for different substrates. In the work reported here, a substrates adoption methodology (SAM) has been developed. The proposed SAM identifies the necessary changes to a template recipe & flowsheet in order to adapt it for a given substrate. The changes can be related to reagents (e.g. reducing agent, solvent, catalyst), process conditions (e.g. operating temperature, flow rates), as well as in the physical arrangement (configuration) of the modular process equipment within the template. In this way the substrates adoption methodology helps to achieve “fast, flexible, future (F3)” pharmaceutical production processes by adapting a recently designed generic modular process-plant. The supporting tools for the substrate adoption are: (1) an ontological knowledge-base consisting of the properties of substances, reaction characteristics and characteristics of unit operations; and (2) a model library consisting of the mathematical models. The objective of this presentation is two-fold: First to highlight the substrates adoption framework and the associated models, methods and tools, and second to demonstrate its applications using a pharmaceutical manufacturing case study involving the nitro reduction of 2-Nitro-4’-chlorodiphenylamine.
Original languageEnglish
Publication date2011
Publication statusPublished - 2011
Event8th European Congress of Chemical Engineering - Berlin, Germany
Duration: 25 Sep 201129 Sep 2011
Conference number: 8
http://www.ecce2011.de/

Conference

Conference8th European Congress of Chemical Engineering
Number8
Country/TerritoryGermany
CityBerlin
Period25/09/201129/09/2011
Internet address

Bibliographical note

F3 Factory project, European Community‘s 7th Framework Program under grant agreement n° 228867

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