Elimination of viruses (human immunodeficiency, hepatitis B, vesicular stomatitis and Sindbis viruses) from an intravenous immunoglobulin preparation.
More than 10(4) plaque-forming units (pfu)/ml of HIV are inactivated during the alcohol fractionation step from plasma to fraction (Fr)-II+III, greater than 10(4) pfu/ml is inactivated from Fr-II+III to Fr-II and greater than 10(4) pfu/ml is inactivated during the polyethylene glycol (PEG) fractionation process from Fr-II+III to intravenous IgG (IVIG). The total inactivation rate from plasma to IVIG via Fr-II+III or Fr-II was calculated to be greater than 10(8) or 10(12), respectively. The PEG fractionation method produces an intact and unmodified IVIG. In addition, the PEG fractionation method at a low ionic strength was found to be effective for the elimination of greater than 10(5) units of other viruses, including hepatitis B, vesicular stomatitis and Sindbis viruses.
Hamamoto
Y
Y
Department of Virology and Parasitology, Yamaguchi University, Japan.
Harada
S
S
Yamamoto
N
N
Uemura
Y
Y
Goto
T
T
Suyama
T
T
D005591:Chemical Fractionation; D004340:Drug Contamination; D000431:Ethanol; D006678:HIV / Q000302:isolation & purification; D006515:Hepatitis B virus / Q000302:isolation & purification; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage / Q000302:isolation & purification*; D007275:Injections, Intravenous; D011092:Polyethylene Glycols; D012845:Sindbis Virus / Q000302:isolation & purification; D014721:Vesicular stomatitis Indiana virus / Q000302:isolation & purification; D014780:Viruses / Q000302:isolation & purification*
D007136:Immunoglobulins; D000431:Ethanol; D011092:Polyethylene Glycols