The advancement and application of process analytical technology (PAT) in pharmaceutical manufacturing represents a complex task, requiring an understanding of both historical developments and modern technological methods. This book provides a comprehensive overview of the current use of various analytical tools and methods within the industry and how they can be applied to PAT. It covers topics such as sampling innovation, statistical process control, and the utilization of chemometrics, all pivotal for maintaining and improving product quality. The text delves into methods like near-infrared spectroscopy, Raman spectroscopy, and spectrophotometry, discussing their principles, applications, and benefits in real-time monitoring and process control. It provides an insight into the continuous manufacturing of solid oral dosage forms, highlighting regulatory considerations and the integration of PAT for enhanced product quality and efficiency. Furthermore, the book explores the role of sensors, liquid chromatography, and mass spectrometry as essential components in monitoring and optimizing manufacturing processes. Unique to this book are the practical examples and case studies that illustrate the implementation of PAT tools across different phases of pharmaceutical development. This makes it an invaluable resource for pharmaceutical scientists, engineers, and technicians, as well as researchers and advanced students in related fields, offering direct insights into innovative practices and the future direction of pharmaceutical manufacturing.
Table of Contents:
1. From Benchtop to Manufacturing…
Gregory K. Webster, Greg D. Doddridge, and Laila Kott
2. Sampling the Critical “Before Analysis” Domain
Rodolfo J. Romañach and Kim H. Esbensen
3. Optimizing Good Pharmaceutical Practice through Statistical Process Control
Mostafa Essam Eissa
4. Chemometrics for PAT
Zhenqi Shi and Benoit Igne
5. Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms
John Wahlich
6. Sensors in PAT
Charu Pandey
7. Process NIR
Philip Doherty and Owen Rehrauer
8. The Use of Raman Spectroscopy in Pharmaceutical PAT
Bradford B. Behr, Shaun Fraser, and Mark S. Kemper
9. Process Spectrophotometry
Gregory K. Webster
10. Online HPLC as a Process Analytical Technology
Junliang Liu, Yusuke Sato, Paloma Prieto, Vaso Vlachos, and Jason Hein
11. Benchtop NMR in Process Analytical Technology
Anh Le McClain, Blake David Fonda, and Hector Robert
12. Process Headspace Monitoring
James Veale
13. Process Mass Spectrometry
Patrick A. McVey
14. Process FBRM
Wei Li, Wenqing Tian, and Huaiyu Yang
15. Terahertz Spectroscopy in Tablet Manufacturing
Moritz Anuschek, Jukka Rantanen, and J. Axel Zeitler
16. Process Analytical Technology in Bioprocessing
Shailesh Karavadra, Arnaud Di Bitetto, David James, Lin Chen, Juan Villa, Matthew Zustiak, Elizabeth Amoako, David Kuntz, Nimesh Khadka, Lin Zhang, Kevin Broadbelt and Sue Woods
17. Method Validation and Transfer
Greg D. Doddridge
18. Regulatory Consideration for PAT
Laila Kott
About the Author :
Gregory K. Webster is an analytical chemist with over 30 years of pharmaceutical industry experience, spanning early-phase drug development through commercial manufacturing for human and animal health products. He holds a BS from St. Xavier College, an MS from Governors State University, and a PhD from Northern Illinois University. He is the editor of several books published by Jenny Stanford Publishing, including Supercritical Fluid Chromatography: Advances and Applications in Pharmaceutical Analysis (2014), Poorly Soluble Drugs: Dissolution and Drug Release (2016), and Chromatographic Method Development (2020).
Greg D. Doddridge received his BS in biochemistry from Purdue University and MS in chemistry from Indiana University–Purdue University Indianapolis. He has 23 years’ experience in pharma, including sampling, spectroscopy (NIR, Raman), chemometrics/multivariate data analysis, and analytical method development and validation. Since joining AbbVie in 2018, he has led the small molecule drug product PAT and rapid spectroscopy efforts. Prior to joining AbbVie, he worked at Eli Lilly and Zoetis.
Laila Kott is the senior director of Quality Control at Emergent BioSolutions and owner of Skipping Stone Scientific. She earned her BS in chemistry from the University of Toronto, MS in chemistry from the University of Waterloo, and PhD in bioanalytical chemistry from the University of Massachusetts. Dr Kott’s industrial experience spans from early-stage to late-stage to post-approval commitments. She has experience working in several large pharmaceutical companies, contract labs, and biotech startups. Her analytical background reflects her deep knowledge of many analytical techniques, which is echoed in her list of publications, including her previous book with Jenny Stanford Publishing, Chromatographic Method Development (2020).
