Document 0313
 DOCN  M9460313
 TI    Theoretical and technical concerns in inactivation/elimination of
       viruses in plasma derivatives.
 DT    9408
 AU    Hilfenhaus J; Niedrig M; Nowak T; Research Laboratories, Behringwerke
       AG, Marburg.
 SO    Dev Biol Stand. 1993;81:117-23. Unique Identifier : AIDSLINE
       MED/94229365
 AB    To know the virus eliminating/inactivating capacity of the manufacturing
       process of a plasma protein, it is essential to analyse it by adding
       virus to the source material or to different materials obtained at
       various stages of the manufacturing procedure and then to determine the
       elimination/inactivation of this virus. To carry out such experiments
       properly, three prerequisites have to be fulfilled: (i) the
       manufacturing procedure must be scaled down as exactly as possible; (ii)
       relevant test viruses have to be selected for the spiking experiments
       and (iii) the resulting samples must be assayed properly for infectious
       virus. The successful reduction of a manufacturing procedure to a more
       than 1000-fold smaller scale has to be validated to prove that it
       corresponds to the production scale. The most important viruses of risk
       in human plasma are hepatitis B virus (HBV), hepatitis C virus (HCV) and
       human immunodeficiency virus (HIV). HIV is the only one of these viruses
       which can be tested in vitro. A decision has therefore to be made
       concerning which other viruses should be used. The selection of test
       viruses depends on (i) the relationship of these candidates to the
       viruses of risk; (ii) the possibility of growing them to high titres in
       vitro and (iii) the availability of accurate infectivity assays. The use
       of highly sensitive assays is necessary to be able to determine small
       amounts of residual viruses. Since such assays are based on a 7 to 28
       day incubation of the virus samples on cell cultures, these samples must
       be sterile and non-cytotoxic.(ABSTRACT TRUNCATED AT 250 WORDS)
 DE    Biological Products/ADVERSE EFFECTS/ISOLATION & PURIF/*STANDARDS
       Containment of Biohazards  Drug Contamination/PREVENTION & CONTROL
       Human  Models, Biological  Plasma/*MICROBIOLOGY  Risk  Safety
       Sensitivity and Specificity  Virology/INSTRUMENTATION/*METHODS
       Virulence  Viruses/ISOLATION & PURIF/*PHYSIOLOGY/PATHOGENICITY  JOURNAL
       ARTICLE  REVIEW  REVIEW, TUTORIAL

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