RESUMO
AIM: To experimentally assess activity and safety of anti-anthrax intravenous immunoglobulin manufactured on standard technology. MATERIALS AND METHODS: Plasma from selected donors vaccinated with combined anthrax vaccine was tested by enzyme immunoassay. Samples of plasma with increased titer of anti-anthrax antibodies were merged in one manufacturing load and fractionated in ethanol at negative temperature according to standard technology. Formulation of intravenous immunoglobulin was manufactured according to standard technology of acid-enzyme hydrolysis. RESULTS: Proved medical technology of donors immune plasma fractionation provided 4 - 8-fold concentration of anti-anthrax antibodies. The finished product contained 5% of protein and was apyrogenic, non-toxic, thermostable, electrophoretically homogenous, had pH 6.65 and meet the requirements for manufacturing batches of human intravenous immunoglobulin. CONCLUSION: Protective effects of experimental human anti-anthrax immunoglobulin were comparable with control biological--equine anti-anthrax immunoglobulin for intramuscular use.
