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EP38449
Abstract: • A comprehensive characterization of therapeutic mAbs is critical. PTMs including oxidation, deamidation, glycosylation may significantly alter the efficacy and safety of the protein drug.
• Regulatory agencies require a full characterization of the biological and chemical heterogeneity of any biological drug product.
• This work focuses on the utility of the maXis II UHR QTOF for rapid screening of mAbs at the intact protein and peptide level for sequence characterization and MAM analysis.
• The automated workflow is implemented using BioPharma Compass software which encompasses data acquisition, processing and reporting using a seamless workflow solution.Summary: This work focuses on the utility of the maXis II UHR QTOF for rapid screening of mAbs at the intact protein and peptide level for sequence characterization and MAM analysis.
• Regulatory agencies require a full characterization of the biological and chemical heterogeneity of any biological drug product.
• This work focuses on the utility of the maXis II UHR QTOF for rapid screening of mAbs at the intact protein and peptide level for sequence characterization and MAM analysis.
• The automated workflow is implemented using BioPharma Compass software which encompasses data acquisition, processing and reporting using a seamless workflow solution.Summary: This work focuses on the utility of the maXis II UHR QTOF for rapid screening of mAbs at the intact protein and peptide level for sequence characterization and MAM analysis.
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