Document 0307
 DOCN  M9460307
 TI    Viral validation of the manufacturing process of high purity albumin
       from placentas.
 DT    9408
 AU    Grandgeorge M; Veron JL; Pasteur Merieux Serums & Vaccins, Marcy
       l'Etoile, France.
 SO    Dev Biol Stand. 1993;81:237-44. Unique Identifier : AIDSLINE
       MED/94229379
 AB    We report on the viral validation of an industrial purification process
       which is used to manufacture high purity human albumin from frozen
       placentas. This process has been used without any modification since
       1980 except for a progressive increase in production scale to reach a
       capacity of 19 tons of placentas per day. The extraction purification
       process includes five alcohol manufacturing steps, some with strict
       conditions of alcohol concentration, acid pH, temperature and one
       including chloroform. These steps are followed by three
       chromatographies. Albumin is finally submitted to pasteurization both in
       bulk and in the final container. Selected steps of this process have
       been tested for their ability to remove or inactivate viruses. Viruses
       used were HBV, HIV-1, HIV-2 and model viruses poliovirus, avian
       reovirus, MuLV, Sindbis, SV40 and Aujeszky's. In vitro infectivity
       titration assays were used for all viruses except for HBV where DNA and
       antigen titrations were performed. Reduction factors obtained were from
       10 to 29 log10 depending on the viral marker. Moreover, testing done on
       regular production batches demonstrated the absence of HBV, HIV-1 and
       HCV genomic sequence in the final lots. Viral risk calculation for HBV,
       HIV-1 and HCV was made considering the maximal theoretically possible
       contamination of the starting material. This calculation showed the very
       large safety margin the manufacturing process with respect to virus
       transmission for these viruses or possibly other unknown ones.
 DE    Albumins/*ISOLATION & PURIF  Blood/MICROBIOLOGY  Chromatography
       Comparative Study  Female  Human  Hydrogen-Ion Concentration
       Placenta/*CHEMISTRY/MICROBIOLOGY  Precipitation  Pregnancy  Pregnancy
       Complications, Infectious/MICROBIOLOGY  Pregnancy Proteins/*ISOLATION &
       PURIF  Reference Standards  Risk  Safety  Virus
       Diseases/MICROBIOLOGY/PREVENTION & CONTROL/TRANSMISSION
       Viruses/*ISOLATION & PURIF/PHYSIOLOGY/ULTRASTRUCTURE  JOURNAL ARTICLE

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