Roy / Centanni Biotechnology Operations

Principles and Practices
Erscheinungsjahr 2012
ISBN: 978-1-4398-9403-3
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: 0 - No protection

E-Book, Englisch, 416 Seiten

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.

Zielgruppe

Undergraduate and graduate students in biotechnology and pharmaceutical sciences; pharmacists; professionals working in the biotechnology and drug industries (or for government); professional patent attorneys; and professors in biotechnology and pharmaceutical technology.

Autoren/Hrsg.

Roy, Michael J.

Centanni, John M.

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie

Inhaltsverzeichnis

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

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 Questions

Über Autor(innen)

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.