Table 2.
Impurity profile of Remicade® and Remsima™ before and after 4-week incubation at 40°C and 97% relative humidity.
| Remicade® |
Remsima™ |
||||||
|---|---|---|---|---|---|---|---|
| Method | Attribute | 0 days | 4 weeks | Statistics | 0 days | 4 weeks | Statistics |
| SEC | Dimer, % | 0.1 ± 0.0 | 12.7 ± 1.1 | P < 0.005 | 0.4 ± 0.0 | 12.4 ± 0.5 | P < 0.005 |
| NTA | Number of subvisible particulates 50–350 nm, 10*7 | 2.99 ± 0.49 | 7.43 ± 1.96 | NS | 21.1 ± 1.60 | 33.9 ± 3.59 | P < 0.005 |
| IM MS | Fragment 50 kDa, % | — | 19.7 ± 2.7 | N/A | — | 26.5 ± 14.2 | N/A |
| Fragment 100 kDa, % | — | 6.0 ± 1.1 | N/A | — | 9.1 ± 3.4 | N/A | |
| Dimer, % | 0.8 ± 0.2 | 3.3 ± 0.6 | P < 0.1 | 2.0 ± 2.5 | 2.9 ± 1.2 | NS | |
| Trimer, % | — | 0.2 ± 0.1 | N/A | — | 0.2 ± 0.1 | N/A | |
| SDS | Aggregate, % | 24.1 | 37.5 | N/A | 23.8 | 40.8 | N/A |
| Fragment, % | 7.0 | 14.1 | N/A | 0.0 | 0.4 | N/A | |
| LC-MS | Deamidation LC-N158, % | 0.6 ± 0.1 | 7.5 ± 0.7 | P < 0.05 | 0.5 ± 0.4 | 7.5 ± 0.5 | P < 0.05 |
| Deamidation HC-N57, % | 1.7 ± 0.2 | 17.6 ± 1.9 | P < 0.05 | 2.2 ± 0.1 | 18.9 ± 0.8 | P < 0.05 | |
| Deamidation HC-N392, % | 1.3 ± 0.1 | 10.3 ± 1.8 | NS | 0.5 ± 0.1 | 11.2 ± 1.5 | P < 0.05 | |
| Activity | TNF binding, % | 100.0 ± 3.0 | 81.8 ± 4.4 | NS | 111.7 ± 3.1 | 77.2 ± 5.9 | P < 0.01 |
| FcγRIIIa binding, KD (nM) | 173 ± 56 | 545 ± 117 | P < 0.1 | 368 ± 160 | 680 ± 22 | NS | |
Data shown are percentages (n = 2 lots ± SD), N/A – not applicable, NS – not significant.