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.
eBook - ePub
Process Analytical Technology and Data Analysis for the Manufacturing of Biologics
- 172 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
Process Analytical Technology and Data Analysis for the Manufacturing of Biologics
About this book
Information
Table of contents
- Cover Page
- Half-Title Page
- Title Page
- Copyright Page
- Contents
- List of Contributors
- About the Editors
- Foreword
- 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
- Index
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Yes, you can access Process Analytical Technology and Data Analysis for the Manufacturing of Biologics by Amine Kamen,Mario Jardon,Rupa Haldavnekar in PDF and/or ePUB format, as well as other popular books in Technology & Engineering & Food Science. We have over 1.5 million books available in our catalogue for you to explore.