Abstract

Due to the complex nature of protein therapeutics, there are unique challenges and opportunities to implement a Quality by Design (QbD) approach for the biotechnology-derived products. This chapter describes bioprocessing schemes for both liquid and lyophilized drug products. The International Conference on Harmonization (ICH) guidance documents are discussed in the context of bioprocessing to provide examples of the systematic QbD approach. Additionally, this chapter discusses the role of process analytical technologies (PAT) and design of experiments (DoEs) as complementary approaches in upstream and downstream process could serve to support the overall development and manufacture of a quality product. The ultimate goal of QbD is a well-understood process and high-quality product with a commitment to continuous improvement.

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