Document 0309
 DOCN  M9460309
 TI    Partitioning and inactivation of viruses during isolation of albumin and
       immunoglobulins by cold ethanol fractionation.
 DT    9408
 AU    Morgenthaler JJ; Omar A; ZLB Central Laboratory, Swiss Red Cross Blood
       Transfusion; Service, Bern.
 SO    Dev Biol Stand. 1993;81:185-90. Unique Identifier : AIDSLINE
       MED/94229373
 AB    Albumin solutions invariably transmitted infectious hepatitis viruses
       before the introduction of pasteurisation in the final container.
       Immunoglobulin solutions (the older intramuscular as well as the current
       intravenous ones), on the other hand, only rarely transmitted hepatitis.
       The apparent safety of the latter was usually attributed to the presence
       of neutralizing antibodies and to the fractionation process. It was
       shown that viruses tend to concentrate in those fractions of the cold
       ethanol precipitation procedure which are used neither for albumin nor
       for immunoglobulin preparations. Additionally, ethanol alone inactivates
       some viruses, albeit much less at low temperatures than at room
       temperature. According to EC-directives, all manufacturers of stable
       blood products must introduce production steps which inactivate viruses
       or they have to prove that certain production steps, which are already
       being used, do inactivate viruses. In either case, the inactivation has
       to be validated with appropriate experiments. Procedures that are now
       recognized as virucidal are, e.g., pasteurisation (i.e., heating of the
       liquid product at 60 degrees C for 10 hours), solvent/detergent (S/D)
       treatment, photodynamic treatment, or incubation at pH4 with pepsin.
 DE    Albumins/*ISOLATION & PURIF  Alcohol, Ethyl/*PHARMACOLOGY
       Blood/*MICROBIOLOGY  Comparative Study  False Negative Reactions
       Hepatitis C/TRANSMISSION  Human  Hydrogen-Ion Concentration
       HIV/ISOLATION & PURIF  HIV Infections/TRANSMISSION
       Immunoglobulins/*ISOLATION & PURIF  Pepsin A/PHARMACOLOGY  Precipitation
       Safety  Solvents/*PHARMACOLOGY  Viruses/*DRUG EFFECTS/ISOLATION & PURIF
       JOURNAL ARTICLE  REVIEW  REVIEW, TUTORIAL

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