A Universal Pre-Clinical Solution for the Bioanalysis of Fully Human Therapeutic Monoclonal Antibodies in Plasma

机译：血浆中全人治疗单克隆抗体的生物分析的通用前临床溶液

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A MSIA for universal application in the bioanalysis of fully human therapeutic mAbs for pre-clinical research is achievable. Both the raw and the deconvolved HRAM mass spectra generated clearly showed the presence of posttranslational modifications on adalimumab and SILULite from Sigma (data not shown), thus making MSIA amiable for complex in vivo biotransformation studies and Drug Antibody Ratio (DAR) determination.

机译：可实现普遍应用在临床前研究中全人治疗MAB的生物分析中的MSIA。生成的原始和解向HRAM质谱层都显示出从Sigma（未示出的数据）上对Adalimalab和硅藻土的发生发生后改变的存在，从而使MSIA在体内生物转化研究中复合物和药物抗体比（DAR）测定。

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《ASMS Conference on Mass Spectrometry and Allied Topics》|2015年||共1页
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Kwasi Antwi; Eric E. Niederkofler; Urban A. Kiernan;
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2. A universal surrogate peptide to enable LC-MS/MS bioanalysis of a diversity of human monoclonal antibody and human Fc-fusion protein drug candidates in pre-clinical animal studies [J] . FurlongM.T., OuyangZ., WuS., Biomedical Chromatography: An International Journal Devoted to Research in Chromatographic Methodologies and Their Applications in the Biosciences . 2012,第8期

机译：一种通用替代肽，可在临床前动物研究中对多种人类单克隆抗体和人类Fc融合蛋白候选药物进行LC-MS / MS生物分析
3. Dual universal peptide approach to bioanalysis of human monoclonal antibody protein drug candidates in animal studies [J] . FurlongM.T., ZhaoS., MylottW., Bioanalysis . 2013,第11期

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4. The development of the validated LCMS bioanalysis of trastuzumab in human plasma using a selective detection method for complementarity-determining regions of monoclonal antibodies: nano-surface and molecular-orientation limited (nSMOL) proteolysis [J] . Iwamoto Noriko, Yamane Naoe, Umino Yukari, Analytical methods . 2015,第21期

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5. A Universal Pre-Clinical Solution for the Bioanalysis of Fully Human Therapeutic Monoclonal Antibodies in Plasma [C] . Kwasi Antwi, Eric E. Niederkofler, Urban A. Kiernan ASMS Conference on Mass Spectrometry and Allied Topics . 2015

机译：血浆中全人治疗单克隆抗体的生物分析的通用前临床溶液
6. Pre-Clinical Biophysical Characterization of Therapeutic Antibodies in Human Serum by Analytical Ultracentrifugation [D] . Wright, Robert T. 2018

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7. Development of human monoclonal antibodies to diphtheria toxin: A solution for the increasing lack of equine DAT for therapeutic use? [O] . Kris Huygen 2016

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8. A universal solution for eliminating false positives in myeloma due to therapeutic monoclonal antibody interference [O] . John R. Mills, Mindy C. Kohlhagen, Maria A. V. Willrich, 2018

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A Universal Pre-Clinical Solution for the Bioanalysis of Fully Human Therapeutic Monoclonal Antibodies in Plasma

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