Table 3. Quantification of purified lots of mAb2 by RP-UPLC.
Lot | Process intermediate | Reported color | Conc. (g/L) | RP HPLC B12 (ppm) | ng B12/mg Protein1 |
---|---|---|---|---|---|
Lot 1 | Protein A Pool | Strongly pink | 12.8 | 1.49 | 116.4 |
Lot 2 | Protein A Pool | Pink | 12.2 | 0.81 | 66.7 |
Column 2 Pool | Colorless | 6.5 | 0.25 | 39.2 | |
Column 3 Pool | Pink | 12.6 | 0.49 | 39.2 | |
DS | Pink | 21.9 | 0.88 | 40.4 | |
Lot 3 | Protein A Pool | Colorless | 21.6 | 0.18 | 8.3 |
Column 2 Pool | Colorless | 11.9 | 0.06 | 5.1 | |
Column 3 Pool | Colorless | 9.4 | 0.05 | 5.8 |
1 Assuming a molecular weight of 150 kD for mAbs, a conversion factor of 11 070 may be used to obtain B12-Protein molar ratio.