High Throughput and Multiplexed LC-MS/MS Bioanalysis of Therapeutic Monoclonal Antibodies for Preclinical Pharmacokinetic Studies

摘要

1. Immunoaffinity LC-MS/MS method offers an alternative to LBAs for mAb bioanalysis with additional advantages. 2. The multiplexed mAb assay using unique surrogate peptides allows applications for cassette dosing in preclinical and allows quicker preclinical evaluation of mAb candidates. 3. The uniformly labeled SILAC-mAb internal standard ensures assay robustness. 4. Sensitivities, accuracy, precision and throughput sufficiently meet the needs for preclinical PK studies. 5. Similar approach is applicable to other biotherapeutics.