Artificial Intelligence in the Production of Biotherapeutics: Principles, Practices, and Standards

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

Dr. Alok Kumar Srivastav is an accomplished Assistant Professor in the Department of Health Science at the University of the People, Pasadena, California, USA. His academic background includes a Ph.D., M.Tech, and M.Sc. in Bio-Technology, a Post-Doctoral Fellowship (Research) in Bio-Technology from Lincoln University College, Malaysia, and an MBA in Human Resource Management. He is a distinguished figure in Academia and Research, honored with the “International Pride of Educationist Award” at AIT, Thailand, in 2022 for pioneering contributions to advancing education in the digital era, and recipient of a prestigious “Innovative Academic Researcher Award” at HULT, France, UK, in 2024 for his exceptional creativity, innovation, and impact in academic research.

Dr. Priyanka Das serves as an Assistant Professor in the Department of Health Science at the University of the People in Pasadena, California, USA. She holds a Ph.D., M.Tech, and M.Sc. in Biotechnology along with an MBA in Human Resource Management. Prior to her current position, she was a Post-Doctoral Fellowship (Research) in Biotechnology at Lincoln University College, Malaysia. Dr. Priyanka Das is a dedicated scholar, contributing significantly to the field of Biotechnology.