Biotechnology Operations: Principles and Practices

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ISBN 9781439830277
Cat# K11486



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ISBN 9781439830284
Cat# KE11373



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  • Provides an introduction to each key biotechnology development subject, all compiled in one volume
  • Incorporates an integrated approach, tying together the seven key functional areas
  • Emphasizes the need to both plan and integrate an operations program, offering the information required to successfully lead such efforts
  • Uses relatively simple language, clarifies jargon, and uses diagrams to describe processes, making concepts easy to understand


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 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.

Table of Contents

Introduction 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


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



Additional Reading

Practical Problems and Questions

Author Bio(s)

Michael 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.