This case study reviews how quality-by-design principles can be implemented in an intermediate chromatography purification step that uses cation-exchange chromatography.Abstract
Hui Xiang
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Articles by Hui Xiang
The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.
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Establishing Process Design Space for a Chromatography Purification Step: Application of Quality-by-Design PrinciplesPublished: November 2nd 2015 | Updated:
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