Process analytical technology in Downstream-Processing of Drug Substances– A review

Peter Neugebauer, Manuel Zettl, Daniel Moser, Johannes Poms, Lisa Kuchler, Stephan Sacher*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

Abstract

Process Analytical Technology (PAT) has revolutionized pharmaceutical manufacturing by providing real-time monitoring and control capabilities throughout the production process. This review paper comprehensively examines the application of PAT methodologies specifically in the production of solid active pharmaceutical ingredients (APIs). Beginning with an overview of PAT principles and objectives, the paper explores the integration of advanced analytical techniques such as spectroscopy, imaging modalities and others into solid API substance production processes. Novel developments in in-line monitoring at academic level are also discussed. Emphasis is placed on the role of PAT in ensuring product quality, consistency, and compliance with regulatory requirements. Examples from existing literature illustrate the practical implementation of PAT in solid API substance production, including work-up, crystallization, filtration, and drying processes. The review addresses the quality and reliability of the measurement technologies, aspects of process implementation and handling, the integration of data treatment algorithms and current challenges. Overall, this review provides valuable insights into the transformative impact of PAT on enhancing pharmaceutical manufacturing processes for solid API substances.

Original languageEnglish
Article number124412
JournalInternational Journal of Pharmaceutics
Volume661
DOIs
Publication statusPublished - 15 Aug 2024

Keywords

  • Crystallization
  • Downstream processing
  • Drug substance
  • Drying
  • Filtration
  • Process analytical technology (PAT)
  • Workup

ASJC Scopus subject areas

  • Pharmaceutical Science

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