Research Article
Pharmacokinetic Comparability of a Biosimilar Trastuzumab Anticipated from Its Physicochemical and Biological Characterization
Table 1
Isoelectric point by cIEF.
| | Brand | Batch | Main isoform (pI units) | Most acidic isoform (pI units) | Most basic isoform (pI units) | Global pI (pI units) |
| | Herceptin | N35893 | 8.68 ± 0.01 | 7.93 ± 0.13 | 8.94 ± 0.03 | 8.60 ± 0.00 | | B3423B020 | 8.70 ± 0.01 | 8.04 ± 0.10 | 9.00 ± 0.06 | 8.62 ± 0.01 | | B3417B010 | 8.72 ± 0.01 | 8.04 ± 0.12 | 8.86 ± 0.03 | 8.62 ± 0.01 |
| | Trastuzumab-Probiomed | TZPP12002 | 8.69 ± 0.01 | 7.97 ± 0.11 | 8.97 ± 0.12 | 8.60 ± 0.01 | | TZPP12003 | 8.69 ± 0.00 | 7.95 ± 0.08 | 8.84 ± 0.00 | 8.59 ± 0.01 | | TZPP14001 | 8.69 ± 0.02 | 8.05 ± 0.14 | 8.99 ± 0.16 | 8.60 ± 0.03 |
|
|
Variation is presented as confidence interval at 95% ().
|
