Full Description
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling.
Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Contents
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 Process.- 25 Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process.- 26 Product Homogeneity Assessment during Validation of Biopharmaceutical Drug Product Manufacturing Processes.- 27 Application of Quality by Design Principles to the Drug Product Technology Transfer Process.- 28 Regulatory Considerations For Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management.
