An Overview of Quality by Design for Drug Product

The foundation for success of Quality by Design (QbD) for biologics is in place. QbD practices have already added significant value to developing biologic processes and to a deeper understanding of manufacturing processes. In the case of drug product, processes are similar for many products and prior knowledge can be extensively leveraged. Interactive effects, linkage of unit operations, and design space are more easily studied than for API because conditions are intentionally held within certain well-defined ranges, and no further purification usually occurs. For these reasons, biologic drug product is particularly well suited for the application of QbD principles and approaches, both in terms of the relative ease of application and the potential benefits to the industry. In this book, examples will help to catalyze further development and broader application of the QbD methodology to drug product development, with gains in terms of greater process knowledge, more rapid development, avoidance of pitfalls, and greater ease of implementing changes within a well-defined design space.