       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).

