Article ID Journal Published Year Pages File Type
7630699 Journal of Pharmaceutical and Biomedical Analysis 2015 10 Pages PDF
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
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