Quality by Design for Biopharmaceuticals: Principles and Case Studies

Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process.

Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation.

In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as:

• The understanding and development of the product's critical quality attributes (CQA)
• Development of the design space for a manufacturing process
• How to employ QbD to design a formulation process
• Raw material analysis and control strategy for QbD
• Process Analytical Technology (PAT) and how it relates to QbD
• Relevant PAT tools and applications for the pharmaceutical industry
• The uses of risk assessment and management in QbD
• Filing QbD information in regulatory documents
• The application of multivariate data analysis (MVDA) to QbD

Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.Content:
Chapter 1 Quality by Design: An Overview of the Basic Concepts (pages 1–8): Rohin Mhatre and Anurag S. Rathore
Chapter 2 Considerations for Biotechnology Product Quality by Design (pages 9–30): Steven Kozlowski and Patrick Swann
Chapter 3 Molecular Design of Recombinant Malaria Vaccines Expressed by Pichia pastoris (pages 31–52): David L. Narum
Chapter 4 Using a Risk Asses