Quantitative analysis of hIgG1 in monkey serum by LC–MS/MS using mass spectrometric immunoassay. (May 2016)

• Record Type: Journal Article
• Authors: Lanshoeft, Christian; Heudi, Olivier; Cianférani, Sarah; Warren, Andrew P; Picard, Franck; Kretz, Olivier
• Is Part Of: Bioanalysis. Volume 8:Number 10(2016)
• Page Start: 1035
• Page End: 1049
• Publication Date: 2016-05
• Subjects: generic LC–MS/MS assay -- generic surrogate peptide -- hIgG1 -- mass spectrometric immunoassay disposable automation research tips -- therapeutic proteins; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.16.32
• Languages: English
• ISSNs: 1757-6180

Abstract

Aim: A sensitive generic LC–MS/MS method for hIgG1 quantification in cynomolgus monkey serum using mass spectrometric immunoassay disposable automation research tips (MSIA-D.A.R.T.'S™) is reported.Results: The hIgG1 was captured with a biotinylated mouse anti-hIgG antibody (50.0 µg/ml) targeting the fragment crystallizable (Fc) region. Elution from the streptavidin-coated MSIA-D.A.R.T.'s was conducted with 0.4% trifluoroacetic acid in water. The method was selective and linear from 10.0 to 1000 ng/ml using 100 µl of serum. The method was evaluated regarding accuracy, precision, carry-over, dilution, auto-sampler stability and applied for the determination of hIgG1 concentration in monkey serum after intravitreal administration.Conclusion : The present assay is suitable for quantitative analysis of hIgG1-based therapeutic proteins in monkey serum at low levels.