[New immunoglobulin for treatment of anthrax].
OBJECTIVE
To experimentally assess activity and safety of anti-anthrax intravenous immunoglobulin manufactured on standard technology.


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.


CONCLUSIONS
Protective effects of experimental human anti-anthrax immunoglobulin were comparable with control biological--equine anti-anthrax immunoglobulin for intramuscular use.
Borovskiĭ
D V
DV
Shevtsov
A N
AN
Darmov
I V
IV
Lub
M Iu
MIu
Zaĭtseva
G A
GA
Drobkova
A V
AV
Dolmatov
V Iu
VIu
D000818:Animals; D000881:Anthrax / Q000628:therapy*; D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology; D000918:Antibody Specificity; D001408:Bacillus anthracis / Q000276:immunology; D005591:Chemical Fractionation; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D011817:Rabbits
D000907:Antibodies, Bacterial; D016756:Immunoglobulins, Intravenous