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M9460307.TXT
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1994-06-12
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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).