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OverviewBecause 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 Practices reflects 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. Full Product DetailsAuthor: John M. Centanni (University of Wisconsin-Madison, USA) , Michael J. Roy (University of Wisconsin-Madison, Madison, USA)Publisher: Taylor & Francis Inc Imprint: CRC Press Inc Dimensions: Width: 15.60cm , Height: 2.00cm , Length: 23.50cm Weight: 0.726kg ISBN: 9781439830277ISBN 10: 1439830274 Pages: 416 Publication Date: 22 March 2011 Audience: College/higher education , General/trade , Tertiary & Higher Education , General Replaced By: 9781498758796 Format: Hardback Publisher's Status: Active Availability: Awaiting stock  The supplier is currently out of stock of this item. It will be ordered for you and placed on backorder. Once it does come back in stock, we will ship it out for you. Table of ContentsIntroduction to Biotechnology Operations: Planning for Success Biotechnology Operations Marketing, Financial and Business Considerations for Development Product Development Planning Summary of Planning for Success Project Management Project Management in Biotechnology Background of Project Management Project Management in Biotechnology Project Management in Biotechnology Operations Project Management with Contracts and Collaborations Tools for Effective Project Management Summary of Project Management in Biotechnology Development Regulatory Affairs The U.S. Food and Drug Administration: Law and Regulations for Biopharmaceuticals FDA-Regulated Products U.S. FDA Regulatory Information and Resources: Regulatory Intelligence Regulatory Operations for FDA Applications Summary on Regulatory Affairs Activities in Biotechnology Operations Regulatory Compliance Regulatory Compliance Quality Systems to Meet Regulatory Compliance Compliance for Biopharmaceuticals: Other Regulations of Importance Inspection and Enforcement Compliance with Non-FDA Regulations: International, National, State and Local Quality Systems Overview of Quality in Biotechnology History: Evolution of Quality Concepts and Practices Quality Systems Approach to Product Development Planning a Quality System Hallmarks of Quality: Fundamental Criteria for Building Effective Quality Systems Quality Assurance Unit Initiate a Quality System for a Biotechnology Operation Unique and Effective Approaches to Quality Management Quality Systems for Research Resolving Quality Issues or Problems Summary of Quality Systems Biomanufacture Overview of Biomanufacturing Requirements Design in Biomanufacture Technical Considerations for Biomanufacture Phases and Scale Up: The Biomanufacturing Life Cycle Raw Material Considerations Compliance and Quality in Biomanufacture: Current Good Manufacturing Practices Biomanufacturing Processes for Biotechnology Products Final Product: Formulation Fill, Finish and Labeling Biomanufacturing Facilities, Utilities and Equipment Contract Manufacturing Options Validation of Biomanufacturing Facilities, Utilities, Equipment and Processes Summary of Biomanufacture Quality Control Quality Control Overview Certificate of Analysis for Drug Product In-Process Testing Analytical Methods Additional Analytical Tools and Concepts Quality Control of Cell Banks Samples and Sampling Analytical Controls and Reference Standards Test Failures, Out-of-Specification Results and Retesting Testing for Product Stability Quality Control Testing of Raw Materials Quality Control and the Manufacturing Environment Qualification, Validation and Verification of Analytical Methods Application of Statistics in Assay Performance and Validation Summary of Quality Control Nonclinical Studies Nonclinical Studies and Risk Assessment Biopharmaceutical Delivery, Pharmacokinetics and Pharmacodynamics Safety Assessment of Biopharmaceuticals Quality of Nonclinical Studies: Current Good Laboratory Practices Summary of Nonclinical Studies Clinical Trials Introduction to Clinical Trials Background of Clinical Research Organization of Clinical Research Infrastructure for a Clinical Trial: Individuals, Documents and Investigational Product Clinical Trial Operations Quality Systems for Clinical Trials: Current Good Clinical Practices Summary on Clinical Trials Glossary Additional Reading Practical Problems and QuestionsReviewsAuthor InformationMichael J. Roy, Ph.D., RAC, is an adjunct professor in the Master of Science Biotechnology Program in the School of Medicine and Public Health at the University of Wisconsin--Madison. He teaches Biotechnology Operations and Project Management and Leadership. He has successfully developed biopharmaceutical and medical device products for more than 22 years, serving as a consultant in biotechnology since 2001. Much of his work has focused on early development of novel biotechnology products and medical devices with emphasis on product development planning, regulatory affairs, quality systems, and project management. He received a Ph.D. in Pathology from University of Wisconsin--Madison, an MS in Tropical Medicine and Medical Parasitology from Louisiana State University Medical Center, and a BS in Biology from the University of Wisconsin--Platteville. In addition, he holds Regulatory Affairs Certification (RAC). Mr. Roy is a retired colonel in the U.S Army. While serving, he was involved in the development of in vitro diagnostics and vaccines and in establishing ISO (International Organization of Standards) quality systems at the U.S. Army Medical Research Institute of Infectious Diseases, Ft. Detrick. Tab Content 6Author Website:Countries AvailableAll regions |
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