Catalogue


Biotechnology operations : principles and practices /
Michael J. Roy.
imprint
Boca Raton : CRC Press, [2011?].
description
xv, 415 p.
ISBN
1439830274 (hardcover : alk. paper), 9781439830277 (hardcover : alk. paper)
format(s)
Book
Holdings
More Details
imprint
Boca Raton : CRC Press, [2011?].
isbn
1439830274 (hardcover : alk. paper)
9781439830277 (hardcover : alk. paper)
general note
"CRC title."
abstract
"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.
catalogue key
7605191
 
Includes bibliographical references and index.
A Look Inside
Reviews
This item was reviewed in:
Reference & Research Book News, June 2011
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Summaries
Main Description
Because of rapid developments in the biotechnology industry ”and the wide range of disciplines that contribute to its collective growth ”there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a comprehensive, practical guide to fundamentals. Filling the void, Biotechnology Operations: Principles and Practicesreflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology: Biomanufacturing Clinical trials Nonclinical studies Project management Quality assurance Quality control Regulatory affairs A practical roadmap to optimizing biotechnology operations, this reference illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional areas. Applying lessons learned throughout the nascent history of biotech, author Michael Roy highlights developmental principles that could bring future products to market more safely and efficiently. Drawing from his experiences working in industry and teaching a graduate course at the University of Wisconsin, this hotly anticipated book clarifies basic methodologies and practices to help reduce risks and resolve problems as future technological discoveries are developed into tangible products.
Main Description
Because of rapid developments in the biotechnology industry-and the wide range of disciplines that contribute to its collective growth-there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a comprehensive, practical guide to fundamentals. Filling the void, Biotechnology Operations: Principles and Practicesreflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology: Biomanufacturing Clinical trials Nonclinical studies Project management Quality assurance Quality control Regulatory affairs A practical roadmap to optimizing biotechnology operations, this reference illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional areas. Applying lessons learned throughout the nascent history of biotech, author Michael Roy highlights developmental principles that could bring future products to market more safely and efficiently. Drawing from his experiences working in industry and teaching a graduate course at the University of Wisconsin, this hotly anticipated book clarifies basic methodologies and practices to help reduce risks and resolve problems as future technological discoveries are developed into tangible products.
Main Description
Based on the author's five years of teaching this book introduces key biotechnology developments covering the critical elements of such as project management, regulatory affairs, quality assurance, biomanufacturing, quality control, nonclinical safety testing, and clinical evaluation. The author discusses these subjects in relation to development planning, process and pathways, management of integrated projects and the business and economic aspects of development. It describes the functional areas that must be successfully integrated to bring a biotechnology product to market, using simple language and explanatory figures.
Library of Congress Summary
"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.
Bowker Data Service Summary
Based on the author's five years of teaching, this text introduces key biotechnology developments covering the critical elements of such as project management, regulatory affairs, quality assurance, biomanufacturing, quality control, nonclinical safety testing, and clinical evaluation.
Main Description
Based on the author's five years of teaching, this book introduces key biotechnology developments and covers critical elements such as project management, regulatory affairs, quality assurance, biomanufacturing, quality control, nonclinical safety testing, and clinical evaluation. The author discusses these subjects in relation to development planning, process and pathways, management of integrated projects and the business and economic aspects of development. Using simple language and explanatory figures, it describes the functional areas that must be successfully integrated to bring a biotechnology product to market.

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