Exploration on technical difficulties of multipath system in tissue cross-reactivity studies
10.7501/j.issn.1674-6376.2017.10.002
- VernacularTitle:组织交叉试验中多路径体系技术难点的探索和研究
- Author:
bo De QI
1
;
guo Xin WANG
;
Xin FU
;
Min LI
;
Meng XING
;
Xin LI
;
Hua LI
Author Information
1. 济南金域医学检验中心有限公司
- Keywords:
monoclonal antibodies;
tissue cross-reactivity;
immunohistochemistry;
technical difficulties
- From:
Drug Evaluation Research
2017;40(10):1372-1377
- CountryChina
- Language:Chinese
-
Abstract:
Tissue cross-reactivity (TCR) studies play an important role in the preclinical safety evaluation of monoclonal antibody (mAb) drugs.The objective of TCR studies is to find out off-target binding sites of mAbs,and provide valuable predictions for the toxicological evaluation and safety medication in vivo.According to the new drug application requirements of FDA,EMA and CFDA,TCR studies need to be carried out before Phase I clinic trails.As the origin of mAb drugs was transferred from murine antibodies to fully humanized antibodies in current years,immunohistochemical methods used in TCR studies were confronted with some new problems and challenges.Taking our own experiences and recent progress on TCR studies at home and abroad together,the authors summarized the recent exploration on technical difficulties of multipath system in TCR studies.This may provide valuable insight for further improving the quality of TCR studies and increase the predictive value of TCR studies for in vivo toxicological evaluation in China.
