Table 3.
Secondary structure analysis for Rituximab biosimilars and Ristova® as determined using Far UV CD, Fluorescence, FTIR spectroscopy.
| Far UV CD | Intrinsic Fluorescence | FTIR |
|||||
|---|---|---|---|---|---|---|---|
| Drug Product | Batch No. | Negative dip (nm) | λmax (nm) | Alpha helix (%) | Beta sheet (%) | Random coil (%) | Beta turn (%) |
| Ristova® | H0191B01 | 216–218 | 347 | 9.4–9.6 | 57.63–57.74 | 10.29–10.52 | 22.26–22.56 |
| Biosimilar 1 | R1AV01815 | 216 ± 0.6 | 348 | 9.442 ± 0.06 | 57.730 ± 0.03 | 10.461 ± 0.11 | 22.367 ± 0.11 |
| Biosimilar 2 | RMV1A16003 | 218 ± 1.2 | 347 | 9.484 ± 0.04 | 57.929 ± 0.22 | 10.631 ± 0.11 | 21.956 ± 0.03 |
| Biosimilar 3 | 12110010 | 218 ± 2.3 | 349 | 9.440 ± 0.06 | 57.726 ± 0.34 | 10.339 ± 0.21 | 22.494 ± 0.09 |
| Biosimilar 4 | RA1504G | 217 ± 1.0 | 349 | 9.461 ± 0.07 | 57.671 ± 0.18 | 10.440 ± 0.07 | 22.428 ± 0.1 |
| Biosimilar 5 | RA1503D | 217 ± 2.1 | 348 | 9.459 ± 0.03 | 57.632 ± 0.16 | 10.564 ± 0.07 | 22.345 ± 0.09 |