An immunoinhibition approach to overcome the impact of pre-existing antibodies on cut point establishment for immunogenicity assessment of moxetumomab pasudotox.

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作者： Amy K,Schneider ^[1] ; Inna,Vainshtein ^[2] ; Lorin K,Roskos ^[1] ; Carlos,Chavez ^[1] ; Bo,Sun ^[1] ; Meina,Liang ^[3]

作者单位： Clinical Pharmacology & DMPK, Medimmune, LLC, 319 North Bernardo Avenue, Mountain View, CA 94043, USA. ^[1] Clinical Pharmacology & DMPK, Medimmune, LLC, 319 North Bernardo Avenue, Mountain View, CA 94043, USA. Electronic address: vainshteini@medimmune.com. ^[2] Clinical Pharmacology & DMPK, Medimmune, LLC, 319 North Bernardo Avenue, Mountain View, CA 94043, USA. Electronic address: liangm@medimmune.com. ^[3]

关键词 Anti-drug antibodies Biopharmaceuticals Cut point Immunogenicity Immunotoxin Pre-existing antibodies

主题词抗体(Antibodies);抗体, 中和(Antibodies, Neutralizing);细菌毒素类(Bacterial Toxins);生物药学(Biopharmaceutics);外毒素类(Exotoxins);人类(Humans);免疫测定(Immunoassay)

DOI 10.1016/j.jim.2016.05.007

PMID 27220271

发布时间 2018-03-20

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