Process Analytical Technology and Data Analysis for the Manufacturing of Biologics

This book introduces the reader to the complex and multidisciplinary approaches of Process Analytical Technologies (PAT) necessary to meet current biomanufacturing regulatory and quality expectations.

Process Analytical Technology and Data Analysis for Manufacturing of Biologics examines pharmaceutical biomanufacturing opportunities and challenges. The book introduces the principles and methodologies of quality by design (QbD) for biomanufacturing and biopharmaceuticals. It also discusses the fundamentals of process monitoring and control, process data management, storage, and security. The authors also present the collection and analysis of data using cutting-edge analytical methods like real-time tracking and control, multivariate data analysis, and deployment of ML algorithms. The book includes examples, case studies, and problems to facilitate the incorporation of PAT, QbD, and data science curricula in teaching environments.

This book is ideal for students who need an overview of the state-of-the-art in this expanding field and is invaluable for experienced PAT practitioners in biopharmaceuticals manufacturing. It also makes a useful reference and training tool for regulatory officials.

Professor Amine Kamen holds the Canada Research Chair in Bioprocessing of Viral Vaccines at McGill University (retired) and is a Researcher Emeritus at the National Research Council of Canada. He is a leading expert in bioprocess engineering, specializing in the development and manufacturing of viral vectors for vaccination and gene and cell therapy. His research has significantly advanced scalable production platforms for adenovirus, lentiviral, adeno-associated virus (AAV), and Vesicular Stomatitis Viral (VSV) vectors, with applications in vaccine, CAR-T cell therapy and gene editing development. His contributions include the development of serum-free suspension cultures using HEK-293SF and VERO cells, enabling high-yield production of clinical-grade viral vectors. Professor Kamen’s work integrates cell culture engineering, process analytical technologies, and Quality by Design principles to ensure robust and reproducible manufacturing processes. Currently his efforts are directed to advancing mRNA technology for intensification and densification of cost-effective manufacturing processes to enable equitable access. He has authored over 210 peer-reviewed publications and has been instrumental in training the next generation of biomanufacturing professionals through academic and industry collaborations.

Dr. Rupa Haldavnekar is an assistant professor at the University of Oklahoma, School of Electrical and Computer Engineering. She holds a PhD in Biomedical Engineering with focus on surface enhanced Raman scattering (SERS)-based molecular analysis for cancer diagnosis. Currently Dr. Haldavnekar is developing Raman spectroscopy-based process analytical technology for cancer diagnosis. Her research interests also include development of orthogonal methods for investigation of cellular interactions in tumor microenvironment.

Dr. Mario A. Jardon is a Faculty Lecturer at the Department of Bioengineering, McGill University. He holds a PhD degree in Chemical and Biological Engineering. He has several years of experience in biopharmaceutical manufacturing. His scientific expertise includes development and intensification of mammalian cell-based process for recombinant protein production, with a focus on integrating cellular stress responses and metabolism to understand and engineer biological systems responses, with the aim of developing high-performance manufacturing processes used for therapeutic biologics.