BTEC faculty and industry colleague author book on biopharmaceutical manufacturing

Published Oct. 27, 2021

Students in BTEC's new Biopharmaceutical Lyophilization and Spray Drying course utilize scanning electron microscopy.
“Biopharmaceutical Manufacturing: Principles, Processes, and Practices” was recently published by De Gruyter as part of its STEM series.

Gary Gilleskie, BTEC’s executive director, and Charlie Rutter, a senior scientist at BTEC, along with Becky McCuen, director of QA at KBI Biopharma, have jointly authored a book on biopharmaceutical manufacturing, “Biopharmaceutical Manufacturing: Principles, Processes, and Practices.” The book, recently published by Walter de Gruyter GmbH, was written to provide concise, comprehensive, and up-to-date coverage of biopharmaceutical production. The content and clear, informal writing style has been influenced by the authors’ substantial industry and teaching experience, including many questions from university students and industry professionals who have taken courses at BTEC. The authors sought to strike the right balance between practical and theoretical information and to tell a story that benefits a variety of audiences: from students using it as a textbook for a course on biopharmaceutical manufacturing or professionals working in the biopharmaceutical (or a related) industry who simply need information on how biopharmaceutical production is done.

The book includes coverage of the following topics:

  • An up-to-date introduction to biopharmaceutical products
  • Discussion of Good Manufacturing Practice (GMP) standards, which ensure quality is built into these products
  • A review of concepts used in the design of manufacturing facilities
  • An in-depth explanation of bioreactor operations and processes for product harvest, purification, and formulation of biopharmaceuticals
  • Examples based on real-life scenarios within the chapters and problem sets at the end of chapters

NC State’s D.H. Hill Library and Hunt Library hold copies of the book, and the libraries’ online catalog shows availability. The book is available for purchase from the De Gruyter website and Amazon.