Artificial Intelligence in the Production of Biotherapeutics

Principles, Practices, and Standards

Alok Kumar Srivastav, Priyanka Das

• Publisher: CRC Press
• Year: 2025
• eBook ISBN: 9781040385524
• Topic: Biological Sciences
• Subtopic: Biotechnology in Medicine
• Index: Biological Sciences

The transformative role of artificial intelligence (AI) in modern biomanufacturing focuses on key areas such as process analytical technology (PAT), Good Manufacturing Practice (GMP) compliance, predictive analytics, and AI-driven quality systems. It bridges cutting-edge AI applications with the complexities of biotherapeutic production, offering insights into automation, real-time monitoring, and process optimization.

Delving into the core of biomanufacturing, the book provides a structured journey through its critical phases. It begins with an introduction to modern biomanufacturing principles, quality by design approaches, and the integration of AI. Subsequent chapters examine raw material management, lean manufacturing practices, and the application of predictive analytics to optimize supply chains. Readers will explore advanced tools such as AI-enhanced data acquisition in PAT, automated standard operating procedures (SOPs), and AI-driven process controls for fermenters and chromatography systems. The text also addresses GMP essentials, including personnel management, hygienic facility design, and pharmaceutical water systems. Key chapters highlight AI's role in validation processes, sterile packaging, and regulatory compliance, referencing global guidelines from organizations such as the WHO, FDA, and ICH. Real-world case studies featuring therapeutic proteins, monoclonal antibodies, and vaccines underscore the practical applications of AI in scaling and maintaining biotherapeutic production.

This book equips readers with a comprehensive understanding of AI's potential to enhance efficiency, accuracy, and compliance in biomanufacturing. Whether you are a professional, researcher, or student, this guide offers actionable insights into leveraging AI to revolutionize biotherapeutic production while adhering to the highest industry standards.

What You Will Learn:

• Understand how AI enhances every phase of biotherapeutic production, from raw material management to regulatory compliance, optimizing efficiency, accuracy, and quality
• Explore the role of AI in advanced data acquisition, process control, and continuous improvement, including applications in fermenters, flow filtration, and chromatography systems
• Gain insights into leveraging AI for automating standard operating procedures (SOPs), predictive maintenance, quality assurance, and adhering to global GMP standards like WHO and FDA guidelines
• Learn how AI transforms upstream and downstream processes, ensures sterility in packaging, and supports case studies on therapeutic proteins, monoclonal antibodies, and human vaccines
• Discover the potential of AI in shaping the future of biomanufacturing, including challenges, data security, and the ethical implications of AI-driven automation

Table of contents

• Cover
• Half-Title
• Title
• Copyright
• Dedication
• Contents
• Preface
• Acknowledgment
• About the Authors
• Chapter 1 Introduction to Biomanufacturing
• Chapter 2 Raw Material and Compliance in Biomanufacturing
• Chapter 3 Process Analytical Technology
• Chapter 4 Standard Operating Procedures in Biotechnology
• Chapter 5 Introduction to Quality Systems
• Chapter 6 Principles and Practice of GMP: Personnel and Premises
• Chapter 7 Facilities, Equipment, and Pharmaceutical Water
• Chapter 8 Qualification and Process Validation
• Chapter 9 Production, Sanitation, and Sterile Packaging
• Chapter 10 GMP in Regulation
• References
• Index