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Document 0308
DOCN M9460308
TI Chromatographic removal of viruses from plasma derivatives.
DT 9408
AU Burnouf T; Centre Regional de Transfusion Sanguine, Lille, France.
SO Dev Biol Stand. 1993;81:199-209. Unique Identifier : AIDSLINE
MED/94229375
AB Progress in protein separation technology has led to the development of
a new generation of plasma derivatives, generally prepared by procedures
involving one or several chromatographic steps. In addition to providing
two to three log purification factors of several therapeutic products,
with regard to some protein contaminants, chromatography has been shown
to improve the potential safety of new plasma derivatives by
contributing to the removal of plasma-borne viruses. Indeed, validation
studies have demonstrated that each immuno-affinity, ion-exchange, and
heparin affinity chromatography step can eliminate 1 to 5 log of HIV-1,
or of several model viruses, enveloped or non-enveloped, such as sindbis
virus, pseudorabies virus, vesicular stomatitis virus, reovirus 3, or
simian virus 40. Several parameters can be considered as influencing the
chromatographic behaviour of viruses, including the size, shape,
symmetry, and membrane structure. In addition, buffer conditions that
may induce aggregation and change their apparent size and surface
properties, as well as chromatography flow-rate and packing material
characteristics, are, among others, important parameters potentially
influencing the binding of viruses on chromatographic resins. Due to the
complexity of the phenomena potentially influencing the chromatographic
behaviour of viruses, and because these are not well understood, it is
important to design chromatographic production processes of plasma
derivatives and to perform their validation studies following a rigorous
scientific approach.
DE Biological Products/*ISOLATION & PURIF/STANDARDS Blood Coagulation
Factors/ISOLATION & PURIF/STANDARDS Blood Proteins/*ISOLATION &
PURIF/STANDARDS Chromatography/*METHODS Drug Contamination/PREVENTION
& CONTROL Human Plasma/*MICROBIOLOGY Safety Virus Replication
*Viruses/PHYSIOLOGY/ULTRASTRUCTURE JOURNAL ARTICLE REVIEW REVIEW,
TUTORIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).