Quality by Design for Biopharmaceuticals

<b>The concepts, applications, and practical issues of Quality by Design</b> <p>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.</p> <p><i>Quality by Design: Perspectives and Case Studies</i> 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.</p> <p>In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as:</p> <ul> <li>The understanding and development of the product’s critical quality attributes (CQA)</li> <li>Development of the design space for a manufacturing process</li> <li>How to employ QbD to design a formulation process</li> <li>Raw material analysis and control strategy for QbD</li> <li>Process Analytical Technology (PAT) and how it relates to QbD</li> <li>Relevant PAT tools and applications for the pharmaceutical industry</li> <li>The uses of risk assessment and management in QbD</li> <li>Filing QbD information in regulatory documents</li> <li>The application of multivariate data analysis (MVDA) to QbD</li> </ul> <p>Filled with vivid case studies that illustrate QbD at work in companies today, <i>Quality by Design</i> is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.</p>