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Analytical Quality by Design Using Design of Experiments

Summary: At the center of analytical Quality by Design (QbD) is Design of Experiment (DoE). Using DoE, assay development begins with the creation of an analytical target profile to define method objectives including critical method attributes and key method attributes. With CDMOs commonly receiving analytical methods at different stages, a different DoE approach can be used for assays that differ in level of readiness for said CDMO’s assay development pipeline. This scientific poster demonstrates how a panel of analytical assays designed for a mAb used different DoE approaches for rigorous statistical design and analyses for assay development.

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