Abstract
Quality by Design (QbD) is a science- and risk-based approach to drug product development. While many of the same principles have been historically used during development, this knowledge was not always formally documented or proactively submitted to regulators. In recent years, the US Food and Drug Administration has launched an initiative for pharmaceutical quality for the twenty-first century to modernize pharmaceutical manufacturing and improve product quality. In the biopharmaceutical world, the QbD efforts have focused primarily on drug substance development with little emphasis on drug product development. We present a systematic approach to late-stage drug product, especially formulation development using three monoclonal antibody (mAb) examples. While studies using mAb-1 and mAb-2 focus on liquid formulations filled in glass vials, mAb-3 provides an example of a liquid fill in a prefilled syringe. Results generated using these approaches strengthen the data packages to support specifications and manufacturing ranges and hopefully simplify implementation of postapproval changes. A new roadmap for protein formulation development and potential advantages using the QbD approach is also presented.
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Sreedhara, A., Wong, R., Lentz, Y., Schoenhammer, K., Stark, C. (2015). Application of QbD Principles to Late-Stage Formulation Development for Biological Liquid Products. In: Jameel, F., Hershenson, S., Khan, M., Martin-Moe, S. (eds) Quality by Design for Biopharmaceutical Drug Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 18. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-2316-8_7
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DOI: https://doi.org/10.1007/978-1-4939-2316-8_7
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