Biopharmaceutical Manufacturing

Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing.

• Introduces biopharmaceutical products and discusses Good Manufacturing Practice (GMP) standards
• Describes concepts used in the design of manufacturing facilities
• Incorporates examples based on real-life scenarios

Since joining BTEC in 2007, Gary Gilleskie has served in a number of positions, including director of operations from 2012–2017, and is currently BTEC’s acting director. Dr. Gilleskie’s work focuses on the area of downstream processing of biopharmaceuticals, including protein therapeutics and vaccines. While at BTEC, he has developed and taught numerous courses focused on downstream bioprocessing, for audiences ranging from NC State students to industry professionals to the U.S. Food and Drug Administration. He also started BTEC’s bioprocess services program and has collaborated with a number of external organizations on developing processes and new bioprocessing technologies. Prior to joining BTEC, Dr. Gilleskie spent 15 years in both the chemical and biopharmaceutical industries. His biopharmaceutical experience comes from working for Bayer, in their plasma fractionation business unit, and Diosynth Biotechnology, a contract manufacturer of biopharmaceuticals. While at Diosynth, he managed downstream process development and cGMP manufacturing groups. He was involved in the development and manufacture of more than 10 different protein therapeutics produced in a variety of host systems. Dr. Gilleskie received his bachelor's degree in chemical engineering from NC State in 1986 and his doctorate in chemical engineering from the University of Minnesota in 1993.

Charles Rutter, Ph.D. is a Senior Scientist at Corteva Agriscience, where he develops fermentation processes for novel biological products for agricultural applications. He previously worked at BTEC at North Carolina State University.

Becky McCuen is a Quality Director at KBI Biopharma, a biopharmaceutical contract services organization, where she supports development, implementation and quality oversight of the company’s global ERP system.