Integration of Quality by Design (QbD) Principles into Biopharmaceutical Process Engineering Design: A Case Study of Monoclonal Antibody Production
Abstract
This paper explores the integration of Quality by Design (QbD) principles into biopharmaceutical process engineering, with a
focus on monoclonal antibody (mAb) production. Through theoretical modeling and design analysis, the study demonstrates how QbD
frameworkssuch as defining the quality target product profile (QTPP), identifying critical quality attributes (CQAs), and establishing
design spacecan optimize manufacturing processes. The methodology integrates risk assessment, process analytical technologies (PAT),
and statistical design of experiments (DoE) to improve product consistency and regulatory compliance. The findings highlight significant
advancements in manufacturing control and process robustness, reinforcing QbD's value in ensuring product quality from development
through scale-up.
focus on monoclonal antibody (mAb) production. Through theoretical modeling and design analysis, the study demonstrates how QbD
frameworkssuch as defining the quality target product profile (QTPP), identifying critical quality attributes (CQAs), and establishing
design spacecan optimize manufacturing processes. The methodology integrates risk assessment, process analytical technologies (PAT),
and statistical design of experiments (DoE) to improve product consistency and regulatory compliance. The findings highlight significant
advancements in manufacturing control and process robustness, reinforcing QbD's value in ensuring product quality from development
through scale-up.
Keywords
Quality by Design; Biopharmaceutical Engineering; Monoclonal Antibodies; Process Analytical Technology; Critical Quality
Attributes
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PDFReferences
[1] Rathore, A.S., & Winkle, H. (2009). Quality by Design for Biopharmaceuticals. Nature Biotechnology, 27(1), 2634.
[2] ICH Harmonised Tripartite Guidelines. (2009). Pharmaceutical Development Q8(R2). International Conference on Harmonisation.
[3] Yu, L.X. (2008). Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control. Pharmaceutical
Research, 25(4), 781791.
[4] Scott, C., & Wilkinson, D.J. (2017). Application of PAT and QbD Principles to Biopharmaceutical Development. BioProcess International, 15(3), 3846.
[5] Farid, S.S. (2007). Process Economics of Monoclonal Antibody Production. Nature Reviews Drug Discovery, 6(11), 835841.
DOI: http://dx.doi.org/10.70711/pmr.v2i8.8269
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