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Yale J Biol Med. 2017 March; 90(1): 159.
Published online 2017 March 29.
PMCID: PMC5369038
Focus: Drug Development

Biotechnology Operations: Principles and Practices, Second Edition

Reviewed by Gregory A. Breuer

John M. Centanni, Michael J. Roy 
Biotechnology Operations: Principles and Practices, Second Edition.
2017. CRC Press (Taylor & Francis Group): Boca Raton, Florida. ISBN: (Hardcover) 978-1498758796. US $129.95. 496 p.

Biotechnology Operations: Principles and Practices, now in its second edition, is a textbook dedicated to the technical details of the business of biotechnology and bringing products to market by navigating many regulatory hurdles along the way. As readers quickly discover, having a plan is key to a successful biotech venture and the authors spare no details in laying out the organization tools required to move a product forward. Although the book is self-described as following along with seven major areas of biotechnology operations, the book is perhaps more appropriately split into two halves – the business and the science aspects of biotechnology.

The first chapters of the book cover the organizational facets of biotech startups by describing typical management structure, regulatory hurdles, and quality assurance practices that are common in the business. Although the subject matter tends to be rather dry, the authors strike a much-appreciated balance between keeping the text adequately detailed and easy to understand. Fine details are often presented in table format throughout the book in order to improve readability and make for an easy reference should the reader choose to return to these sections at a later date. The latest edition of the book touts an increased number of figures for better understanding of key points, though there are often long stretches throughout the book with no visual aids. This is particularly felt in the chapters on regulatory affairs and regulatory compliance as the text in these chapters is necessarily dense. Continued improvement in both the quantity and quality of figures would be an excellent addition to what is already a great reference.

The second half of the book is largely dedicated to specific techniques employed in biomanufacturing, quality control, clinical and nonclinical research, with updated sections for the emerging fields of tissue engineering and others. These chapters provide an excellent overview of the commonly used methods for the production of things like biologics, devices, and the quality assurance measures expected by regulatory agencies for each of these classes of product and more. It is quite clear that the authors have a tremendous breadth of knowledge in the field as they cover numerous aspects of manufacturing in each of these fields, at times in great detail.

Overall, this book is an excellent choice for graduate-level scientists, researchers, and entrepreneurs in biotechnology who are hoping to gain the technical knowledge necessary for bringing a product all the way from conception through production and eventually to market.

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