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Full Description
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.
Contents
Chapter 1 Introduction - PAT and Digitalization in Pharmaceutical Biomanufacturing Chapter 2 The QbD approach for manufacturing of biologics Chapter 3 PAT tools for process monitoring of biologics manufacturing Chapter 4 Essential analytics framework for PAT data analysis Chapter 5 Application of machine learning in PAT Chapter 6 PAT and Process Control Chapter 7 PAT for Process Modelling Chapter 8 Process data management Chapter 9 Future Perspectives on Process Analytical Technologies and Data Analytics for Biologics Manufacturing Chapter 10 Case Study. PAT in mRNA-LNP manufacturing
