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Even the best of the conventional methods can only measure around 80–90% of the impurities that could potentially be in a drug. There is a risk that the authorities might reject a drug due to the lack of documentation of impurities, which is why some drug manufacturers have never been able to release their product to the market. The opportunity to use mass spectrometry-based protein analysis as documentation for drug purity is therefore a great leap forward for all companies struggling with the limitations of earlier methods, explains Bryant McLaughlin, an experienced CMC executive in the biopharmaceutical industry. Photo: Alphalyse A/S
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