Biotechnology Operations

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.

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