Biotechnology operations

Drawing on industry experience and on a graduate course taught at the University of Wisconsin-Madison within its Master of Science in Biotechnology program, this volume examines how a biotech product gets built from start to finish. Its focus is the operational side of that work: biomanufacturing, clinical and non-clinical studies, project management, quality assurance and control, and regulatory affairs.

The central argument is that these seven functions must be planned in advance and tightly coordinated, since the authors saw in industry how often development projects falter without that discipline. The text is written for graduate students and for people already working in or entering the biotechnology field.