Wanted: Native Protein LC-MS
Complex biologic characterization demands a new era of instrumentation assay technology – the analytical community must seize the opportunity.
Matthew A. Lauber | | Opinion
The biologics field is booming and showing no signs of slowing down. As the biotech industry has developed, it has adopted advanced engineering techniques to produce antibody-drug conjugates (ADCs), bispecific monoclonal antibodies, new types of fusion protein scaffolds – and the products are becoming increasingly complex. Yet complexity is no excuse for compromise when it comes to patient safety or lot-to-lot reproducibility, so analytical assays must be up to the challenge of converting complicated biomolecular puzzles into tractable, well-characterized molecules.
There is no one-size-fits-all method for addressing every characterization challenge presented by these new modalities, but it is reasonable to suggest that LC and MS will play a central role. Advances in LC-MS have made it easier than ever to confirm recombinant protein sequences and to investigate product-related impurities. However, LC separations coupled to MS detection have relied largely on denaturing conditions that afford sensitive detection but also restrict our ability to investigate protein conformations and interactions. In short, techniques that couple native separations to MS analysis are needed.
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