Biotechnology Operations: Principles and Practices

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