Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
7630699 | Journal of Pharmaceutical and Biomedical Analysis | 2015 | 10 Pages |
Abstract
- Whether partial reduction a concern for safety or efficacy was addressed.
- Partially reduced mAb subclasses were re-oxidized quickly in vitro.
- The re-oxidized mAbs are fully assembled/indistinguishable from drug products.
- Partially reduced mAbs are fully potent in cell-based bioassay.
- These results will be very helpful to address concerns from regulatory agencies.
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Tian Wang, Yaoqing Diana Liu, Bing Cai, Gang Huang, Gregory C. Flynn,