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Abstract
Quality by design (QbD) has been receiving a lot of attention in the pharmaceutical
community of late. Successful QbD implementation requires a thorough understanding
of the relationship between the critical quality attributes (CQAs) and the clinical
properties of the product, the relationship between the process and CQAs and the variability
in raw materials. This article presents a roadmap for successful QbD implementation
for therapeutic biotechnology products. The approach presented here is aligned with
existing regulatory guidance documents. Key developments are reviewed and case studies
are used to illustrate these concepts. It is concluded that although several QbD concepts
are being practiced by the biotechnology industry, successful dialogue and partnership
between the industry and its regulators will be the key to successful QbD implementation.