Robustness Evaluation of a Legacy N-Glycan Profiling Method for a Therapeutic Antibody Under ICH Q14 Lifecycle Principles
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Background: This study assesses the robustness of a legacy N-glycan profiling method for the therapeutic antibody MAB1 with different Peptide-N-glycosidase F (PNGase F) enzyme sources, solid phase extraction (SPE) cartridges, and... ...
