Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies.

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作者： Zhandong Don,Zhong ^[1] ; Adrienne,Clements-Egan ^[2] ; Boris,Gorovits ^[3] ; Mauricio,Maia ^[4] ; Giane,Sumner ^[5] ; Valerie,Theobald ^[6] ; Yuling,Wu ^[7] ; Manoj,Rajadhyaksha ^[5]

作者单位： Amgen Inc., One Amgen Center Dr., Thousand Oaks, California, 91320, USA. zhongz@amgen.com. ^[1] Janssen Research and Development LLC, Janssen Biotherapeutics, Spring House, Pennsylvania, USA. ^[2] BioMedicines Design, Pfizer Inc, Andover, Massachusetts, USA. ^[3] Genentech, 1 DNA Way, South San Francisco, California, USA. ^[4] Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA. ^[5] Shire Pharmaceuticals, Lexington, Massachusetts, USA. ^[6] MedImmune, Gaithersburg, Maryland, USA. ^[7]

关键词 anti-drug antibody immunogenicity mitigation neutralizing antibody target interference

主题词抗体, 中和(Antibodies, Neutralizing);交叉反应(Cross Reactions);人类(Humans);免疫测定(Immunoassay);药用制剂(Pharmaceutical Preparations)

DOI 10.1208/s12248-017-0148-7

PMID 29063411

发布时间 2018-11-13

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