TY - JOUR
T1 - Process analytical technology in Downstream-Processing of Drug Substances– A review
AU - Neugebauer, Peter
AU - Zettl, Manuel
AU - Moser, Daniel
AU - Poms, Johannes
AU - Kuchler, Lisa
AU - Sacher, Stephan
N1 - Publisher Copyright:
© 2024 Elsevier B.V.
PY - 2024/8/15
Y1 - 2024/8/15
N2 - 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.
AB - 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.
KW - Crystallization
KW - Downstream processing
KW - Drug substance
KW - Drying
KW - Filtration
KW - Process analytical technology (PAT)
KW - Workup
UR - http://www.scopus.com/inward/record.url?scp=85198005898&partnerID=8YFLogxK
U2 - 10.1016/j.ijpharm.2024.124412
DO - 10.1016/j.ijpharm.2024.124412
M3 - Review article
C2 - 38960339
AN - SCOPUS:85198005898
SN - 0378-5173
VL - 661
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
M1 - 124412
ER -