Quality by design for biopharmaceuticals: a historical review and guide for implementation

Abstract

This article reviews the history of quality-by-design (QbD), how this concept has been applied to biopharmaceuticals, and what can be expected from implementation of QbD. Although QbD may lead to better design of products and manufacturing processes, and offers the potential for reduced regulatory compliance costs, it will likely increase development costs. Process developers will require additional skills and knowledge in the ‘quality disciplines’, which are not normally part of the training of those in biopharmaceutical process development. A model for implementing QbD in biopharmaceutical manufacture is proposed. The reader will gain an understanding of how QbD principles have been applied to the development of biopharmaceuticals, as well as learning of the potential drawbacks of applying QbD tools indiscriminately. Excellent examples of QbD applied to biopharmaceuticals in the literature will be highlighted and suggested as the direction for future development in this area.