Detection of hepatitis C virus RNA in alpha interferon derived from in vitro culture of leukocytes of human origin.
In order to assure the virological safety of blood products, in addition to serological testing of individual donations and virus inactivation steps undertaken during manufacture, routine PCR testing for HCV RNA of starting materials (plasma, cells), intermediates or final product is necessary. The aim of this study was to determine the rate of HCV RNA positive batches of human native leukocyte interferon during large-scale production. Our findings indicate the presence of HCV RNA in 6.1% batches despite acidification of intermediates in order to inactivate Sendai virus.
Forcić
D
D
Institute of Immunology Inc., Rockefellerova 10, Zagreb, 10000, Croatia. dforcic@iz.inet.hr
Zgorelec
R
R
Santak
M
M
Kosutić
T
T
Mazuran
R
R
D001483:Base Sequence; D002478:Cells, Cultured; D004340:Drug Contamination; D016679:Genome, Viral; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D066298:In Vitro Techniques; D016898:Interferon-alpha / Q000737:chemistry* / Q000302:isolation & purification; D007962:Leukocytes / Q000737:chemistry*; D008969:Molecular Sequence Data; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000032:analysis*; D012015:Reference Standards; D012689:Sequence Homology, Nucleic Acid
D016898:Interferon-alpha; D012367:RNA, Viral