Document 0805
 DOCN  M9550805
 TI    Inactivation and elimination of viruses during preparation of human
       intravenous immunoglobulin.
 DT    9505
 AU    Uemura Y; Yang YH; Heldebrant CM; Takechi K; Yokoyama K; Alpha
       Therapeutic Corporation, Los Angeles, CA 90032.
 SO    Vox Sang. 1994;67(3):246-54. Unique Identifier : AIDSLINE MED/95167802
 AB    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.
 DE    Alcohol, Ethyl/PHARMACOLOGY  Alphavirus/DRUG EFFECTS
       Detergents/PHARMACOLOGY  Echoviruses/DRUG EFFECTS  Evaluation Studies
       Fractionation  Heat  Hepatitis C Viruses/DRUG EFFECTS  Human  HIV-1/DRUG
       EFFECTS  HIV-2/DRUG EFFECTS  Immunoglobulins, Intravenous/*ISOLATION &
       PURIF  Mumps Virus/DRUG EFFECTS  Paramyxovirus/DRUG EFFECTS
       Plasma/*VIROLOGY  Polyethylene Glycols/PHARMACOLOGY  Precipitation
       Safety  Solvents/PHARMACOLOGY  Virus Diseases/*PREVENTION &
       CONTROL/TRANSMISSION  *Viruses/DRUG EFFECTS/PHYSIOLOGY  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).