Immunogenicity screening assay development for a novel human-mouse chimeric anti-CD147 monoclonal antibody (Metuzumab)
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- 作者：Li Mia ; 1 ; Wei Lib ; 1 ; Maohua Lic ; Tao Chena ; Muyang Wangc ; Le Sunc ; sunl@antibodychina.com" class="auth_mail" title="E-mail the corresponding author ; Zhinan Chend ; znchen@fmmu.edu.cn" class="auth_mail" title="E-mail the corresponding author
- 关键词：Anti-CD147 mAb (Metuzumab) ; Anti-drug antibody (ADA) ; Immunogenicity ; Bridging ELISA assay
- 刊名：Journal of Immunological Methods
- 出版年：2016
- 出版时间：June 2016
- 年：2016
- 卷：433
- 期：Complete
- 页码：38-43
- 全文大小：340 K
文摘
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Metuzumab Fab-specific mouse monoclonal antibodies and monkey polyclonal antisera were generated as the internal standard and positive controls for ADA.
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A very sensitive Bridging ELISA assay was developed to detect the Metuzumab ADA in the Cynomolgus monkey sera.
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At 1:100 dilution, the highest positive rates (6 out of 8 monkeys) of free ADA were seen in the High-dose group 2-weeks but no significant pathologic and clinic adversary effect was observed in those monkeys.