Table 3.
Isoelectric point by cIEF. Variation is presented as confidence interval at 95% (n = 3).
| Product | Batch | Main isoform (pI units) | Most acidic variant (pI units) |
Most basic variant (pI units) |
Global pI (pI units) |
|---|---|---|---|---|---|
| MabThera | M0605 | 9.31 ± 0.00 | 8.68 ± 0.00 | 9.49 ± 0.00 | 9.07 ± 0.06 |
| N3518 | 9.31 ± 0.00 | 8.68 ± 0.00 | 9.49 ± 0.00 | 9.09 ± 0.06 | |
| B62222 | 9.31 ± 0.00 | 8.68 ± 0.00 | 9.49 ± 0.00 | 9.09 ± 0.06 | |
|
| |||||
| Kikuzubam | 5445130608 | 9.30 ± 0.00 | 8.64 ± 0.00 | 9.42 ± 0.00 | 9.03 ± 0.07 |
| 5445131015 | 9.30 ± 0.01 | 8.64 ± 0.01 | 9.42 ± 0.00 | 9.02 ± 0.08 | |
| 5445131216 | 9.29 ± 0.01 | 8.63 ± 0.01 | 9.42 ± 0.00 | 9.01 ± 0.08 | |