Research Article
Physicochemical and Biological Characterization of a Biosimilar Trastuzumab
Table 4
Monomer content of trastuzumab by SE-UPLC and CGE-NR. Variation is presented as confidence intervals at 95% (
).
| Product | Batch | SE-UPLC (%) | CGE-NR (%) |
| Trastuzumab-Probiomed | TZPP11002 | 99.6 ± 0.0 | 92.3 ± 0.3 | TZPP12001 | 98.9 ± 0.0 | 90.8 ± 1.1 | TZPP11001 | 99.4 ± 0.0 | 96.6 ± 0.4 |
| Reference product | N3597B013 | 98.9 ± 0.1 | 92.8 ± 0.6 | N35973 | 99.7 ± 0.0 | 93.5 ± 0.7 | B34310 | 99.5 ± 0.0 | 93.1 ± 0.4 |
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