Quantitative analysis of hIgG1 in monkey serum by LC-MS/MS using mass spectrometric immunoassay

被引：4
作者：
Lanshoeft, Christian [1 ,2 ]
Heudi, Olivier [1 ]
Cianferani, Sarah [2 ]
Warren, Andrew P. [1 ]
Picard, Franck [1 ]
Kretz, Olivier [1 ]
机构：
[1] Novartis Inst Biomed Res, Drug Metab & Pharmacokinet, Novartis Campus,Fabrikstr 14, CH-4056 Basel, Switzerland
[2] Univ Strasbourg, CNRS, Inst Pluridisciplinaire Hubert Curien, Lab Spectrometrie Masse BioOrgan,UMR 7178, 25 Rue Becquerel, F-67087 Strasbourg, France
来源：
BIOANALYSIS | 2016年 / 8卷 / 10期
关键词：
generic LC-MS/MS assay; generic surrogate peptide; hIgG1; mass spectrometric immunoassay disposable automation research tips; therapeutic proteins; 2-DIMENSIONAL LIQUID-CHROMATOGRAPHY; THERAPEUTIC MONOCLONAL-ANTIBODY; HUMAN-IMMUNOGLOBULIN G1; HIGH-RESOLUTION; HUMAN PLASMA; IMMUNOAFFINITY ENRICHMENT; HIGH-THROUGHPUT; QUANTIFICATION; PROTEINS; DRUG;
D O I：
10.4155/bio.16.32
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
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 (TM)) is reported. Results: The hIgG1 was captured with a biotinylated mouse anti-hIgG antibody (50.0 mu g/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 mu l 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.
引用
收藏
页码：1035 / 1049
页数：15
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