(PRWEB) September 13, 2012
Targeted drug therapies using monoclonal antibodies have been a growing topic of interest and an area of continued development. The promise of this approach has been to deliver a therapeutic (or cytotoxic) agent with greater selectivity thereby reducing toxic side effects. One approach that has been of considerable interest and an area of continued development is antibody-drug conjugates (ADC). These rationally designed conjugates, formed through the chemical linkage of a potent small molecule cytotoxin (drug) to a monoclonal antibody (mAb), have more complex and heterogeneous structures than the corresponding antibodies. The molecular diversity of the components, cytotoxin, and biodegradable linkers, especially those for cancer, is remarkable.
Of paramount importance to regulatory agencies, the selection of the most appropriate analytical methods for a specific ADC must include discernment of the identity, potency and heterogeneity for the biodegradable linker, the cytotoxic drug, and the choice of mAb attachment sites (lysines, inter-chain cysteines, Fc glycans).
Recent improvements in analytical techniques such as protein mass spectrometry and capillary electrophoresis have significantly increased the quality of information that can be obtained for use in product and process characterization, routine lot release and stability testing.
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