Simultaneous Quantification of Free Adalimumab and Infliximab in Human Plasma Using a Target-Based Sample Purification and Liquid Chromatography–Tandem Mass Spectrometry
Autor: | C. Erik Hack, Sabine M Bosman, Mohsin El Amrani, Erik M. van Maarseveen, Alwin D. R. Huitema, Annelies C. Egas |
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Rok vydání: | 2019 |
Předmět: |
Streptavidin
Analyte medicine.drug_class Enzyme-Linked Immunosorbent Assay Mass spectrometry Monoclonal antibody 030226 pharmacology & pharmacy Plasma 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Tandem Mass Spectrometry Liquid chromatography–mass spectrometry adalimumab Journal Article medicine Humans Pharmacology (medical) LC-MS/MS Pharmacology Chromatography medicine.diagnostic_test Tumor Necrosis Factor-alpha Chemistry Elution Adalimumab Antibodies Monoclonal Infliximab Therapeutic drug monitoring therapeutic antibody Biotinylation simultaneous quantification Drug Monitoring infliximab Chromatography Liquid |
Zdroj: | Therapeutic Drug Monitoring, 41(5), 640. Lippincott Williams and Wilkins |
ISSN: | 0163-4356 |
Popis: | BACKGROUND: Therapeutic drug monitoring of tumor necrosis factor alpha (TNF-α) inhibitors such as adalimumab (ADM) and infliximab (IFX) is considered of added value for patients with systemic inflammatory diseases. In contrast to enzyme-linked immunosorbent assay methods, liquid chromatography-tandem mass spectrometry methods allow for simultaneous quantification of multiple target antibodies in 1 run and thus providing a higher sample throughput. We describe a fast sample work-up strategy for the absolute and simultaneous quantification of ADM and IFX therapeutic monoclonal antibodies in human plasma samples using a target-specific sample purification in combination with liquid chromatography-tandem mass spectrometry. METHODS: The sample purification was based on the selective capture of ADM and IFX in human plasma or serum using biotinylated TNF-α (b-TNF-α), which was coated on a streptavidin 96-well plate. After elution, analytes were heat denatured and trypsin digested to obtain signature peptides for quantification. Stable isotopically labeled ADM and IFX were introduced as internal standard before sample purification. RESULTS: The method was successfully validated following current European medicines agency guidelines. The linear dynamic rage for both analytes were 1-32 mcg/mL with an excellent mean coefficient of determination, R = 0.9994 for ADM and 0.9996 for IFX. Within-run and between-run imprecision and accuracy were within acceptance criteria. Cross-validation against enzyme-linked immunosorbent assay method showed a high between-method correlation R = 0.962 for ADM and R = 0.982 for IFX. CONCLUSIONS: This method provides an easy, efficient, and cost-effective workflow for therapeutic drug monitoring patients treated with ADM or IFX. |
Databáze: | OpenAIRE |
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