TABLE 4.
Statistical evaluation of the N-glycan analysis peak profiles of bamlanivimab.
| Peak | ID | GU | Exoglycosidase sequencing - response | Migration time (min) | %Area | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NANase | GALase | HEXase | Aliquot #1 | Aliquot #2 | Aliquot #3 | Median | Std.Dev. | %RSD | Aliquot #1 | Aliquot #2 | Aliquot #3 | Median | Std.Dev. | %RSD | |||
| 1 | M4 | 5.74 | — | — | — | 10.28 | 10.26 | 10.25 | 10.26 | 0.01 | 0.13 | 0.19 | 0.19 | 0.19 | 0.19 | 0.00 | 2.17 |
| 2 | FA2G1S1 | 5.92 | X | — | — | 10.40 | 10.38 | 10.38 | 10.39 | 0.01 | 0.12 | 0.13 | 0.13 | 0.13 | 0.13 | 0.00 | 1.26 |
| 3 | A2G2S1 | 6.18 | x | — | — | 10.57 | 10.55 | 10.55 | 10.56 | 0.01 | 0.12 | 0.12 | 0.11 | 0.11 | 0.11 | 0.00 | 4.37 |
| 4 | A2 | 6.56 | — | — | x | 10.81 | 10.79 | 10.78 | 10.79 | 0.01 | 0.12 | 4.71 | 4.81 | 4.86 | 4.79 | 0.08 | 1.64 |
| 5 | M5 | 6.67 | — | — | — | 10.87 | 10.85 | 10.85 | 10.85 | 0.01 | 0.12 | 0.41 | 0.42 | 0.43 | 0.42 | 0.01 | 2.81 |
| 6 | A2B | 6.89 | x | — | — | 11.02 | 11.00 | 10.99 | 11.00 | 0.01 | 0.13 | 0.32 | 0.32 | 0.29 | 0.31 | 0.02 | 5.52 |
| 7 | FA2 | 7.49 | — | — | x | 11.38 | 11.35 | 11.35 | 11.36 | 0.01 | 0.12 | 73.51 | 73.32 | 73.74 | 73.52 | 0.21 | 0.28 |
| 8 | M6 | 7.59 | — | — | — | 11.44 | 11.42 | 11.42 | 11.42 | 0.01 | 0.09 | 0.70 | 0.66 | 0.67 | 0.68 | 0.02 | 2.63 |
| 9 | N/A | 7.76 | — | — | x | 11.54 | 11.52 | 11.51 | 11.52 | 0.01 | 0.12 | 1.65 | 1.71 | 1.64 | 1.66 | 0.04 | 2.26 |
| 10 | A2G1 | 7.90 | — | x | — | 11.63 | 11.61 | 11.61 | 11.61 | 0.01 | 0.11 | 0.23 | 0.23 | 0.21 | 0.23 | 0.01 | 5.19 |
| 11 | A2B[6]G1 | 8.01 | — | x | — | 11.69 | 11.67 | 11.67 | 11.68 | 0.01 | 0.12 | 0.23 | 0.24 | 0.23 | 0.23 | 0.00 | 1.45 |
| 12 | N/A | 8.26 | — | — | x | 11.84 | 11.82 | 11.82 | 11.83 | 0.01 | 0.12 | 0.94 | 0.95 | 0.92 | 0.93 | 0.02 | 1.84 |
| 13 | FA2[6]G1 | 8.53 | — | x | — | 12.00 | 11.98 | 11.97 | 11.98 | 0.01 | 0.11 | 11.67 | 11.73 | 11.55 | 11.65 | 0.10 | 0.82 |
| 14 | FA2[3]G1 | 8.85 | — | x | — | 12.20 | 12.17 | 12.17 | 12.18 | 0.01 | 0.12 | 4.22 | 4.21 | 4.12 | 4.18 | 0.05 | 1.24 |
| 15 | FA2G2 | 9.87 | — | x | — | 12.81 | 12.78 | 12.78 | 12.79 | 0.01 | 0.11 | 0.99 | 0.98 | 0.93 | 0.96 | 0.03 | 3.40 |
| Total afucosylated (incl. high mannose) peaks (%) | 9.56 | %RSD median - all peaks (>0.01%) | 0.12 | %RSD median - all peaks (>0.01%) | 2.46 | ||||||||||||
| Total terminal galactosylated peaks (%) | 17.25 | %RSD median - %area below 1% | 0.12 | %RSD median - %area below 1% | 3.06 | ||||||||||||
| Total high mannose peaks (%) | 1.29 | %RSD median - %area between 1 and 5% | 0.12 | %RSD median - %area between 1 and 5% | 1.71 | ||||||||||||
| Total sialylated peaks (%) | 0.55 | %RSD median - %area over 5% | 0.12 | %RSD median - %area over 5% | 0.55 | ||||||||||||