Abstract
On July 2, 2008, the Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, Food and Drug Administration (FDA) published a Federal Register notice for their Quality by Design (QbD) pilot program. The program was designed to define clinically relevant attributes for protein products regulated by OBP and link them to manufacturing processes. The program considered QbD approaches to unit operations in supplements as well as original biologic license applications (BLA). The pilot program accepted six original BLA applications and four postapproval supplements. This chapter summarizes key observations from the pilot program submissions and meetings for monoclonal antibody products related to the application of QbD concepts to biotechnology product development and manufacture.
Views in this article, other than current Food and Drug Administration (FDA) and International Committee for Harmonization (ICH) guidance, are presented by the authors for consideration. They do not necessarily reflect current or future FDA policy.
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The authors would like to thank Sean Fitzsimmons for review of the manuscript and helpful discussions.
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Rellahan, B., Kozlowski, S., Swann, P. (2015). Lessons Learned from Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program. 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_2
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DOI: https://doi.org/10.1007/978-1-4939-2316-8_2
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