TABLE 1.

Purity and homogeneity of recombinant PpAMA1 FVO and PpAMA1 3D7

TestMethodaResult for:
PpAMA1 FVOPpAMA1 3D7
General safety21 CFR 610.11PassPass
Pyrogenicity21 CFR 610.13bPassPass
Sterility21 CFR 610.12PassPass
EndotoxinLAL gel clot<0.06 EU/ml<0.06 EU/ml
Host cell proteinWestern blotting0.09% (wt/wt)0.09% (wt/wt)
IntegritySDS-PAGE (nonreducing)96.9% full-length AMA197.6% full-length AMA1
IntegritySDS-PAGE (reducing)81.9% full-length AMA148.4% full-length AMA1
MassElectrospray mass spectrometry61,910 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.