Biotechnology Operations : Principles and Practices, Second Edition

This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points. "This book resulted from experiences gained working in biotechnology and while teaching a graduate course entitled Biotechnology Operations and offered to graduate students in the Master of Science (M.S.) in Biotechnology Program at the University of Wisconsin-Madison (http://www.ms-biotech.wisc.edu/ ). In this course we examine the undertaking of developing biotechnology products, focusing on the scientific and management skills of biomanufacturing, clinical trials, non-clinical studies, project management, quality assurance, quality control, and regulatory affairs. The course emphasizes both operational planning for success and integration of plans and efforts in these seven functional areas. The instructors realized from their experience in the biotechnology industry the great need to carefully plan and fully integrate biotechnology development projects. The course is taught in that manner and this book reflects that philosophy with the outcome is a practical guide for students and for those employed or interested in biotechnology"--Provided by publisher. Introduction To Biotechnology Operations : Planning For Success -- Project Management -- Regulatory Affairs -- Regulatory Compliance -- Quality Systems -- Biomanufacture -- Quality Control -- Nonclinical Studies -- Clinical Trials. John M. Centanni And Michael J. Roy. Michael J. Roy's Name Appears First In The Previous Edition. Includes Bibliographical References And Index. Content: Introduction to biotechnology operations : planning for success -- Project management -- Regulatory affairs -- Regulatory compliance -- Quality systems -- Biomanufacture -- Quality control -- Nonclinical studies -- Clinical trials.