Snakebite causes a large amount of morbidities and mortalities in Africa. The safety, efficacy, and homogeneity of anti-
snake venoms are crucial for
snakebite treatments to be effective with minimal adverse effects. We assessed the homogeneity of preparations of three different batches of Combipack
snake venom antiserums (Pan Africa) [CSVAPA] by quantitatively analysing F(ab')2,
IgG, and other contaminating
proteins of plasma. LC-MS/MS analysis showed that approximately 92.4% of the
proteins from the CSVAPA samples was
IgG/F(ab')2 and the percent composition of contaminating
proteins in CSVAPA varied from 0.07 to 4.6%. Batch 1 of the CSVAPA also contained a minor amount of undigested
IgG and F(ab')2 aggregates. CSVAPA contained more than 60%
venom-specific
antibodies, showed moderate complement activation, no
IgE contamination, safe level of
endotoxin, and also showed pre-clinical safety. The immuno cross-reactivity of CSVAPA against 14 Viperidae and Elapidae
snake venoms of Africa was tested by ELISA and immunoblotting, and the neutralization of major enzymatic
venom activities, demonstrating that high molecular weight (>50 kDa)
venom proteins are better recognized/neutralized compared to relatively low molecular weight (<20 kDa)
venom proteins. CSVAPA at a dose of 3-12 times higher than the clinical dose did not cause deaths or adverse reaction of treated rabbits. The results suggest the satisfactory quality, safety, and efficacy of CSVAPA.