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- W2184050147 abstract "METHODS Purpose: To develop a generic approach for quantitation of total (bound and free) therapeutic monoclonal antibodies (mAb) in human serum using immunocapture and mass spectrometric detection of unique surrogate tryptic peptides. Method: Anti-IgG1 mAb was used to capture BAN2401 from 10 µL human serum. A sensitive and specific tryptic peptide of BAN2401 was selected as a surrogate in multiple-reaction-monitoring for absolute quantitation. A second tryptic peptide from an unrelated human IgG1 antibody was used as internal standard to track the analyte through the entire process from immunocapture, digestion and LC-MS/MS analysis. LC-MS/MS analysis involved reverse phase gradient HPLC conditions using an API5500 MS/MS system under positive ion conditions. Results: An existing ELISA was not adequate to quantify BAN2401 in human serum, whereas the improved sensitivity of LC-MS/MS method does. The validated method has a lower limit of quantitation of 500 ng/mL, which is 12-time lower than counterpart ELISA immunoassay developed for the same drug. Upper limit of quantitation is 150 µg/mL. Method imprecision and inaccuracy was less than 20%. Selectivity was confirmed in control serum from both healthy and Alzheimer subjects, and is the major advantage of this method over immunoassay, resulting in a lower LLOQ. Method performance was evaluated by using both mAb and the isotope labeled surrogate peptide as internal standards. The LCMS/MS method reproducibility was demonstrated by successfully cross validating with the original ELISA using both quality control samples and clinical incurred serum samples. To our knowledge this is the first publication comparing incurred clinical sample results obtained from ELISA methodology to those obtained from LC-MS/MS. Because of the generic nature of anti-IgG1 antibody’s affinity to monoclonal antibodies and commercially availability, this approach can be applied to any other mAb quantitation in biomatrices as long as a unique surrogate peptide can be identified from tryptic digestion of mAb. Conclusion: A fully validated LC-MS/MS assay has been developed to support the clinical trial of BAN2401. This generic approach can be applied to any antibody with a unique surrogate peptide." @default.
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- W2184050147 date "2012-01-01" @default.
- W2184050147 modified "2023-09-28" @default.
- W2184050147 title "A Generic Approach for Absolute Quantitation of the Monoclonal Antibody BAN2401 in Human Serum Using Immunocapture and Mass Spectrometric Detection" @default.
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