Lanshoeft, Christian, Heudi, Olivier, Cianférani, Sarah, Warren, Andrew Paul, Picard, Franck and Kretz, Olivier (2016) Quantitative analysis of hIgG1 in monkey serum by LC-MS/MS using mass spectrometric immunoassay. Bioanalysis.

Abstract

Background: A sensitive LC-MS/MS method for human immunoglobulin G1 (hIgG1) quantification in monkey serum using mass spectrometric immunoassay disposable automation research tips (MSIA-D.A.R.T.s) is reported. Results: The hIgG1 was captured with biotinylated mouse anti-hIGg1 antibody targeting the fragment crystallizable (Fc) region (50.0 µg/ml) using 1000 cycles. 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 10.0-1000 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. Conclusions: The present assay is suitable for quantitative analysis of hIgG1 based therapeutic (fusion-) proteins in monkey serum at low levels.

Item Type:	Article
Keywords:	mass spectrometric immunoassay; immunoglobulin G1; LC-MS/MS; therapeutic proteins
Date Deposited:	26 Apr 2016 23:45
Last Modified:	26 Apr 2016 23:45
URI:	https://oak.novartis.com/id/eprint/27519