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What orthogonal HCP analysis reveals about HCPs in mAbs

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In this client case, HCP ELISA and an initial mass spectrometry (LC-MS) analysis of the monoclonal antibody (mAb) process samples indicated that it was very pure.
However, applying our native digest approach substantially lowered the LOD - and revealed potentially problematic HCPs in the client’s drug substance.
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Alphalyse helps biotech and pharmaceutical companies improve their understanding of the Host Cell Protein (HCP) in preclinical and clinical drugs. This knowledge enables better optimization of the downstream process for optimal removal of HCPs. If you would like to know more, visit our website
However, applying our native digest approach substantially lowered the LOD - and revealed potentially problematic HCPs in the client’s drug substance.
-------
Alphalyse helps biotech and pharmaceutical companies improve their understanding of the Host Cell Protein (HCP) in preclinical and clinical drugs. This knowledge enables better optimization of the downstream process for optimal removal of HCPs. If you would like to know more, visit our website