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M9460690.TXT
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Document 0690
DOCN M9460690
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).