Inactivation and elimination of viruses during preparation of human intravenous immunoglobulin.
We report here the results of our evaluation of virus inactivation during the manufacturing steps of two intravenous immunoglobulin (IGIV) preparations. Virus inactivation and/or removal by processing steps, such as ethanol fractionation and polyethylene glycol precipitation, and deliberate virucidal steps, such as solvent/detergent treatment and pasteurization, were tested on a variety of human pathogenic and experimental model viruses, including human immunodeficiency, Hepatitis C, Mumps, Vaccinia, Chikungunya, Vesicular Stomatitis, Sindbis, and ECHO viruses. All viruses were successfully inactivated and/or eliminated by the processing steps studied. In some cases, however, multiple steps were required. We conclude that the incorporation of steps deliberately designed to inactivate or remove viruses during the production of IGIV provides an extra measure of viral safety.
Uemura
Y
Y
Alpha Therapeutic Corporation, Los Angeles, CA 90032.
Yang
Y H
YH
Heldebrant
C M
CM
Takechi
K
K
Yokoyama
K
K
D000524:Alphavirus / Q000187:drug effects; D005591:Chemical Fractionation; D011232:Chemical Precipitation; D003902:Detergents / Q000494:pharmacology; D029822:Enterovirus B, Human / Q000187:drug effects; D000431:Ethanol / Q000494:pharmacology; D005069:Evaluation Studies as Topic; D015497:HIV-1 / Q000187:drug effects; D015498:HIV-2 / Q000187:drug effects; D016174:Hepacivirus / Q000187:drug effects; D006358:Hot Temperature; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000302:isolation & purification*; D009109:Mumps virus / Q000187:drug effects; D010949:Plasma / Q000821:virology*; D011092:Polyethylene Glycols / Q000494:pharmacology; D018108:Respirovirus / Q000187:drug effects; D012449:Safety; D012997:Solvents / Q000494:pharmacology; D014777:Virus Diseases / Q000517:prevention & control* / Q000635:transmission; D018406:Virus Physiological Phenomena; D014780:Viruses / Q000187:drug effects
D003902:Detergents; D016756:Immunoglobulins, Intravenous; D012997:Solvents; D000431:Ethanol; D011092:Polyethylene Glycols