Innovative process development and production concepts for small-molecule API manufacturing

John M. Woodley*

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingBook chapterResearchpeer-review


Although high-molecular-weight biopharmaceuticals have a growing market, low-molecular-weight (small-molecule) pharmaceutical products remain an important therapeutic agent against disease. Interestingly, several features of small-molecule pharmaceutical production processes make them particularly amenable to innovative process development and production. This should enable faster development, bring manufacturing costs down, and improve the sustainability of the final implemented process. In this chapter, examples will be presented of (computer-aided) tools to assist in the implementation of such innovative process development and production solutions.
Original languageEnglish
Title of host publicationProcess Systems Engineering for Pharmaceutical Manufacturing
EditorsRavendra Singh, Zhihong Yuan
Publication date2018
ISBN (Electronic)978-0-444-63963-9
Publication statusPublished - 2018
SeriesComputer Aided Chemical Engineering


  • Process systems engineering (PSE)
  • Quality-by-design (QbD)
  • Process analytical technology (PAT)
  • Solvent selection
  • Template processes
  • Biocatalysis
  • Process integration
  • Flow chemistry
  • Process intensification

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