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2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
Neubert H, Song A, Lee A, Wei C, Duggan J, Xu K, Woolf E, Evans C, Palandra J, Laterza O, Amur S, Berger I, Bustard M, Cancilla M, Chen SC, Cho SJ, Ciccimaro E, Cludts I, Cocea L, D'Arienzo C, Danan-Leon L, Donato LD, Garofolo F, Haidar S, Ishii-Watabe A, Jiang H, Kadavil J, Kassim S, Kurki P, Blaye OL, Liu K, Mathews R, Lima Santos GM, Niwa M, Pedras-Vasconcelos J, Qian M, Rago B, Saad O, Saito Y, Savoie N, Su D, Szapacs M, Tampal N, Vinter S, Wang J, Welink J, Whale E, Wilson A, Xue YJ. Neubert H, et al. Among authors: saad o. Bioanalysis. 2017 Dec;9(23):1895-1912. doi: 10.4155/bio-2017-4973. Epub 2017 Dec 5. Bioanalysis. 2017. PMID: 29205053 Free article.
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).
Neubert H, Olah T, Lee A, Fraser S, Dodge R, Laterza O, Szapacs M, Alley SC, Saad OM, Amur S, Chen L, Cherry E, Cho SJ, Cludts I, Donato LD, Edmison A, Ferrari L, Garofolo F, Haidar S, Hopper S, Hottenstein S, Ishii-Watabe A, Kassim S, Kurki P, Lima Santos GM, Miscoria G, Palandra J, Pedras-Vasconcelos J, Piccoli S, Rogstad S, Saito Y, Savoie N, Sikorski T, Spitz S, Staelens L, Verthelyi D, Vinter S, Wadhwa M, Wang YM, Welink J, Weng N, Whale E, Woolf E, Wu J, Yan H, Yu H, Zhou S. Neubert H, et al. Among authors: saad om. Bioanalysis. 2018 Dec;10(23):1897-1917. doi: 10.4155/bio-2018-0285. Epub 2018 Nov 29. Bioanalysis. 2018. PMID: 30488729 Free article. Review.
Preclinical pharmacokinetics and pharmacodynamics of DCLL9718A: An antibody-drug conjugate for the treatment of acute myeloid leukemia.
Leipold DD, Figueroa I, Masih S, Latifi B, Yip V, Shen BQ, Dere RC, Carrasco-Triguero M, Lee MV, Saad OM, Liu L, He J, Su D, Xu K, Vuillemenot BR, Laing ST, Schutten M, Kozak KR, Zheng B, Polson AG, Kamath AV. Leipold DD, et al. MAbs. 2018 Nov-Dec;10(8):1312-1321. doi: 10.1080/19420862.2018.1517565. Epub 2018 Oct 2. MAbs. 2018. PMID: 30183491 Free PMC article.
Development of a semi-automated MHC-associated peptide proteomics (MAPPs) method using streptavidin bead-based immunoaffinity capture and nano LC-MS/MS to support immunogenicity risk assessment in drug development.
Lee MV, Saad OM, Wong S, LaMar J, Kamen L, Ordonia B, Melendez R, Hassanzadeh A, Chung S, Kaur S. Lee MV, et al. Among authors: saad om. Front Immunol. 2023 Nov 10;14:1295285. doi: 10.3389/fimmu.2023.1295285. eCollection 2023. Front Immunol. 2023. PMID: 38022649 Free PMC article.
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