Quality by Design for Biopharmaceutical Drug Product Development, Softcover reprint of the original 1st ed. 2015
AAPS Advances in the Pharmaceutical Sciences Series, Vol. 18

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.

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.

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. Feroz received his Master’s degree in Pharmaceutics from the University of Delhi and his Ph.D in Pharmaceutics from the University of Connecticut. His publications include a co-edited book, several book chapters and more than 40 peer-reviewed manuscripts and presentations.  He has held multiple leadership positions at the American Association of Pharmaceutical Scientists (AAPS) including chair of the freezing and drying technologies group and lead of the industrial consortium for application of QbD to lyophilization. He is a recipient of two patents in lyophilization formulation and lyophiliztion process development.  Dr. Jameel has received several awards including the AAPS and Parental Drug Association’s Fred Simon Award for the best paper published in the Journal of Pharmaceutical Science and Technology. He has also chaired several symposia on the development of biological products.

Dr. Susan A. Hershenson is the Deputy Director of Chemistry, Manufacturing and Controls at the Bill and Melinda Gates Foundation, where her major responsibilities are to support the CMC development and drug delivery needs for therapeutic projects funded by the Foundation.  She has many years of experience in drug development, including biologics, small molecules, combination products and drug delivery systems. Prior to the Gates Foundation, she served as President of Pharmaceutical Transformations LLC, a consulting service for the pharmaceutical, biotechnology, drug delivery and related industries.  Her clients included a wide range of biotechnology, pharmaceutical and drug delivery companies, start-ups, venture capitals, university labs and non-profit organizations.  Before starting her ownpractice, she served i