43 Tutorial on LC-MS/MS methods quantifying mAbs 46. Ladwig PM, Barnidge DR, Willrich MAV. Mass Spectrometry Approaches for Identification and Quantitation of Therapeutic Monoclonal Antibodies in the Clinical Laboratory. Clin Vaccine Immunol. 2017; 24: e00545-16. 47. Yang Z, Hayes M, Fang X, Daley MP, Ettenberg S, Tse FL. LC-MS/MS approach for quantification of therapeutic proteins in plasma using a protein internal standard and 2D-solid-phase extraction cleanup. Anal Chem. 2007; 79: 9294-9301. 48. Li H, Ortiz R, Tran LT, Salimi-Moosavi H, Malella J, James CA, Lee JW. Simultaneous analysis of multiple monoclonal antibody biotherapeutics by LC-MS/MS method in rat plasma following cassette-dosing. AAPS J. 2013; 15: 337-346. 49. Liu G, Ji QC, Dodge R, Sun H, Shuster D, Zhao Q, Arnold M. Liquid chromatography coupled with tandem mass spectrometry for the bioanalysis of proteins in drug development: practical considerations in assay development and validation. J Chromatogr A. 2013; 1284: 155-162. 50. An B, Zhang M, Johnson RW, Qu J. Surfactant-aided precipitation/on-pellet-digestion (SOD) procedure provides robust and rapid sample preparation for reproducible, accurate and sensitive LC/MS quantification of therapeutic protein in plasma and tissues. Anal Chem. 2015; 87: 4023-4029. 51. Li W, Lin H, Fu Y, Flarakos J. LC-MS/MS determination of a human mAb drug candidate in rat serum using an isotopically labeled universal mAb internal standard. J Chromatogr B Analyt Technol Biomed Life Sci. 2017; 1044-1045: 166-176. 52. Lanshoeft C, Wolf T, Heudi O, Cianferani S, Barteau S, Walles M, Picard F, Kretz O. The use of generic surrogate peptides for the quantitative analysis of human immunoglobulin G1 in pre-clinical species with high-resolution mass spectrometry. Anal Bioanal Chem. 2016; 408: 1687-1699. 53. Kleinnijenhuis AJ, Ingola M, Toersche JH, van Holthoon FL, van Dongen WD. Quantitative bottom up analysis of infliximab in serum using protein A purification and integrated muLC-electrospray chip IonKey MS/MS technology. Bioanalysis. 2016; 8: 891-904. 54. Hagman C, Ricke D, Ewert S, Bek S, Falchetto R, Bitsch F. Absolute quantification of monoclonal antibodies in biofluids by liquid chromatography-tandem mass spectrometry. Anal Chem. 2008; 80: 1290-1296. 55. Ji C, Sadagopan N, Zhang Y, Lepsy C. A universal strategy for development of a method for absolute quantification of therapeutic monoclonal antibodies in biological matrices using differential dimethyl labeling coupled with ultra performance liquid chromatography-tandem mass spectrometry. Anal Chem. 2009; 81: 9321-9328. 56. Li H, Ortiz R, Tran L, Hall M, Spahr C, Walker K, Laudemann J, Miller S, Salimi-Moosavi H, Lee JW. General LC-MS/MS method approach to quantify therapeutic monoclonal antibodies using a common whole antibody internal standard with application to preclinical studies. Anal Chem. 2012; 84: 1267-1273. 57. Yuan L, Arnold ME, Aubry AF, Ji QC. Simple and efficient digestion of a monoclonal antibody in serum using pellet digestion: comparison with traditional digestion methods in LC-MS/MS bioanalysis. Bioanalysis. 2012; 4: 2887-2896. 58. Jiang H, Zeng J, Titsch C, Voronin K, Akinsanya B, Luo L, Shen H, Desai DD, Allentoff A, Aubry AF, Desilva BS, Arnold ME. Fully validated LC-MS/MS assay for the simultaneous quantitation of coadministered therapeutic antibodies in cynomolgus monkey serum. Anal Chem. 2013; 85: 9859-9867. 59. Zhang Q, Spellman DS, Song Y, Choi B, Hatcher NG, Tomazela D, Beaumont M, Tabrizifard M, Prabhavalkar D, Seghezzi W, Harrelson J, Bateman KP. Generic automated method for liquid chromatography-multiple reaction monitoring mass spectrometry based monoclonal antibody quantitation for preclinical pharmacokinetic studies. Anal Chem. 2014; 86: 8776-8784. 2
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