Process Analytical Technology and Data Analysis for the Manufacturing of Biologics

This book introduces Process Analytical Technologies (PAT) for biomanufacturing quality requirements. It covers quality by design, process monitoring, data management, real-time tracking, multivariate analysis, and ML algorithms. Features case studies and examples. it is intended for for students, PAT practitioners, and regulatory officials.

This book introduces the reader to the complex and multidisciplinary approaches of process analytical technologies (PATs) necessary to meet current biomanufacturing regulatory and quality expectations. Process Analytical Technology and Data Analysis for the 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 such as 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 biopharmaceutical manufacturing. It also makes a useful reference and training tool for regulatory officials.