Guidance Document: Validation of a High-Performance Liquid Chromatography-Tandem Mass Spectrometry Immunopeptidomics Assay for the Identification of HLA Class I Ligands Suitable for Pharmaceutical Therapies

被引:28
作者
Ghosh, Michael [1 ,2 ]
Gauger, Marion [1 ]
Marcu, Ana [1 ]
Nelde, Annika [1 ]
Denk, Monika [1 ,3 ,4 ]
Schuster, Heiko [1 ,5 ]
Rammensee, Hans-Georg [1 ,3 ,4 ]
Stevanovic, Stefan [1 ,3 ,4 ]
机构
[1] Univ Tubingen, Inst Cell Biol, Dept Immunol, Tubingen, Germany
[2] Univ Tubingen NMI, Nat & Med Sci Inst, Reutlingen, Germany
[3] German Canc Res Ctr, Partner Site, Tubingen, Germany
[4] German Canc Consortium DKTK, Tubingen, Germany
[5] Immat Biotechnol GmbH, Tubingen, Germany
关键词
MHC CLASS-I; PEPTIDE REPERTOIRE; PROTEOMICS; LANDSCAPE; LEUKEMIA; VACCINE; MOTIFS;
D O I
10.1074/mcp.C119.001652
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
For more than two decades naturally presented, human leukocyte antigen (HLA)-restricted peptides (immunopeptidome) have been eluted and sequenced using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Since, identified disease-associated HLA ligands have been characterized and evaluated as potential active substances. Treatments based on HLA-presented peptides have shown promising results in clinical application as personalized T cell-based immunotherapy. Peptide vaccination cocktails are produced as investigational medicinal products under GMP conditions. To support clinical trials based on HLA-presented tumor-associated antigens, in this study the sensitive LC-MS/MS HLA class I antigen identification pipeline was fully validated for our technical equipment according to the current US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The immunopeptidomes of JY cells with or without spiked-in, isotope labeled peptides, of peripheral blood mononuclear cells of healthy volunteers as well as a chronic lymphocytic leukemia and a bladder cancer sample were reliably identified using a data-dependent acquisition method. As the LC-MS/MS pipeline is used for identification purposes, the validation parameters include accuracy, precision, specificity, limit of detection and robustness.
引用
收藏
页码:432 / 443
页数:12
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