TABLE 1.
Purity and homogeneity of recombinant PpAMA1 FVO and PpAMA1 3D7
| Test | Methoda | Result for:
|
|
|---|---|---|---|
| PpAMA1 FVO | PpAMA1 3D7 | ||
| General safety | 21 CFR 610.11 | Pass | Pass |
| Pyrogenicity | 21 CFR 610.13b | Pass | Pass |
| Sterility | 21 CFR 610.12 | Pass | Pass |
| Endotoxin | LAL gel clot | <0.06 EU/ml | <0.06 EU/ml |
| Host cell protein | Western blotting | 0.09% (wt/wt) | 0.09% (wt/wt) |
| Integrity | SDS-PAGE (nonreducing) | 96.9% full-length AMA1 | 97.6% full-length AMA1 |
| Integrity | SDS-PAGE (reducing) | 81.9% full-length AMA1 | 48.4% full-length AMA1 |
| Mass | Electrospray mass spectrometry | 61,910 Da (predicted mass, 61,904 Da) | —d |
a
CFR, Code of Federal Regulations; LAL, Limulus amoebocyte lysate.
d
—, a clean mass spectrometry chromatogram was not obtainable.