Process Analytical Technology in Pharma: Foundations for the Analytical Scientist

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.

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).