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Development and Validation of platform SEC analysis for proteins based on QbD approach, through Waters Premier SEC column,   15 June 2023

E. Luongo, M. Baldazzi, P. Carletti, I. Longobardo, M. Gabrielli and T. Keller

During the development of a chromatographic method, different parameters must be investigated. In order to reduce the method development timing, a QbD based approach, which allows also to verify the impact of combination among different parameters, is encouraged by recently published ICHQ14 guidance.  In the present study, the application of QbD to the development and validation of a SEC platform assay for monoclonal antibodies by using the Waters Premier Protein SEC 250A 1.7 mm column was shown. Besides to traditional approach where linearity, precision, specificity/diagnostic capability, LOD/LOQ were verified, the robustness of the method by using QbD approach was confirmed. Also, the capability of this SEC method to be used as platform assay not only for mAbs but even for bispecific antibodies characterization as well as for other proteins like enzymes was demonstrated and its suitability as multipurpose assay (titre and aggregation) in purified and partial purified mAb samples to support screening during cell line development and formulation studies will be presented.