Biomanufacturing: Transforming Production of Biolo gics and Biopharmaceuticals

The book provides a comprehensive and forward-looking exploration of the technologies, processes, and innovations that are reshaping the production of biologics and biopharmaceuticals through advanced biomanufacturing.

Biomanufacturing stands at the forefront of a new era in life sciences, reshaping the conception, development, and delivery of advanced biologics and biopharmaceuticals to address global health challenges. Biomanufacturing uses living systems, such as genetically modified cells and microorganisms, to create complex molecules. But these developments also bring about new challenges, such as maintaining strict adherence to Good Manufacturing Practices and ensuring the stability and consistency of biological products. These developments are speeding up production schedules, enhancing product quality, and reducing manufacturing costs. This book offers a comprehensive and forward-looking exploration of the rapidly evolving landscape of biologics production, bringing together contributions from leading experts in biotechnology, engineering, and regulatory science to examine the technologies, strategies, and systems revolutionizing how biologics are developed, scaled, and delivered to patients.

Covering topics such as continuous processing, single-use technologies, process automation, and quality-by-design (QbD), this book serves as both a practical guide and strategic roadmap. It addresses the full biomanufacturing lifecycle―from early-stage development to commercial-scale production―and tackles critical regulatory, scalability, and quality challenges. This essential guide equips you with the insight needed to navigate and lead in this transformative era of pharmaceutical innovation.

Readers will find the volume:

• Explores the latest technologies driving efficiency and innovation in biologics production, including continuous manufacturing and single-use systems;
• Features expert insights from industry leaders, researchers, and regulatory professionals shaping the future of biomanufacturing;
• Covers key regulatory, scalability, and quality challenges with real-world case studies and solutions;
• Bridges academic and industrial perspectives, making it a valuable resource for both newcomers and seasoned professionals.

Audience

This book is designed for professionals and researchers across both academia and industry involved in the development, manufacture and production of biologics and biopharmaceuticals.

Sandip Kunar, PhD is an Associate Professor in the Department of Mechanical Engineering, Aditya University, Surampalem, Andhra Pradesh, India. He has published more than 60 research papers in various reputed international journals and conference proceedings, 60 book chapters, 20 books, and one patent. His research interests include non-conventional machining processes, micromachining processes, biomanufacturing, advanced manufacturing technology, and industrial engineering.

Jagadeesha T., PhD is an Associate Professor in the Mechanical Engineering Department, the National Institute of Technology Calicut, Kerala, India, with more than 25 years of experience. He has developed workbooks and has four patents and more than 75 publications in international journals and conferences. His research interests are advanced machining, additive manufacturing, fluid power control, advanced materials, and vibration and noise control.

D. Sathis Kumar, PhD is the Principal of Aditya Pharmacy College, Surampalem, Andhra Pradesh, India. He has published 54 research articles in esteemed national and international journals, presented papers at reputed conferences, and authored one book. His primary research areas include analytical method development, statistical optimization using software tools, green analytical chemistry, phytochemical analysis, and quality control studies.