Quality by Design for Biopharmaceutical Drug Product Development

1 Challenges and Opportunities for Biotech Quality by Design.- 2 Lessons Learned From Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program.- 3 Definitions and Scope of Key Elements of QbD.- 4 An Overview of Quality by Design for Drug Product.- 5 Development of Drug Product Formulations: Molecular Design and Early Candidates Screening.- 6 Approaches for Early Developability Assessment of Proteins to Guide Quality by Design of Liquid Formulations.- 7 Application of QbD Principles to Late-stage Formulation Development for Biological Liquid Products.- 8 Application of QbD Principles for Lyophilized Formulation Development.- 9 Drug Substance Frozen Storage and Thawing.- 10 Quality by Design as Applied to Drug Substance Formulation using Ultrafiltration and Diafiltration.- 11 A QbD Approach in the Development and Scale-up of Mixing Processes.- 12 Application of QbD Elements in the Development and Scale-up of a Commercial Filtration Process.- 13 Application of QbD Elements in the Development and Scale-up of Commercial Filling Process.- 14 Lyophilization Process Design and Development Using QbD Principles.- 15 Visible and Subvisible Protein Particle Inspection Within a QbD-based Strategy.- 16 Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products.- 17 Quality by Design for Primary Container Components.- 18 Devices and Combination Products for Biopharmaceuticals.- 19 Applicability of QbD for Vaccine Drug Product Development.- 20 Automation and High Throughput Technologies in Biopharmaceutical Drug Product Development with QbD Approaches.- 21 Critical Quality Attributes, Specifications, and Control Strategy.- 22 Multivariate Analysis for Process Understanding, Monitoring, Control and Optimization in Lyophilization Processes.- 23 Using Mathematical Modeling and Prior Knowledge for QbD in Freeze-drying Processes.- 24 Application of Multivariate Statistical Process Monitoring to Lyophilization

Dr. Feroz Jameel is a Principal Scientist for Parenteral Product & Process Development at Amgen Inc., in Thousand Oaks, CA, where he is involved in the development, optimization, scale-up and transfer to manufacturing of biopharmaceutical products.