Subunit Analysis of Monoclonal Antibodies Using Biozen 3.6 µm Intact XB-C8

Abstract:

Fragmentation of monoclonal antibodies is a Critical Quality Attribute (CQA) which must be measured for all biotherapeutics to assess the purity and integrity of the protein. In this technical note, we employ a forced reduction approach to identify and report scFc and F(ab’)2 profiles for two common mAbs through an IdeS digestion. We then look at the fragmentation patterns of a Dithiothreitol (DTT) reduction, which provides separated heavy chain (HC) and light chains (LC).

Document Type:

Technical Notes

Industries:

Pharmaceutical/Biopharmaceutical

Techniques:

HPLC / UHPLC

Brands:

bioZen

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