Abstract
The development of processes for the production of biologics using principles of quality by design (QbD) has started to gain momentum. However, not all stakeholders are fully convinced of its positive implications on process performance and economics. This chapter examines how successfully the purported benefits of QbD have translated into real benefits from both technical and economic points of view. In this pursuit, we present selected case studies from upstream, downstream, and other key activities in a product’s commercialization lifecycle, and assess them with respect to the observed impact of QbD implementation on cost savings, process understanding, raw material variability, speed of transition to the market, and evolution of a platform approach towards commercialization. The increasing role of knowledge management tools as a facilitator of QbD implementation is also discussed and emphasized.
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