Inactivation of HIV, HBV, HCV related viruses and other viruses in human plasma derivatives by pasteurisation.
Laboratory studies were made to verify the capacity and efficacy of the pasteurisation step (heat treatment at 60 degrees C for 10 hours in stabilized aqueous solution) in inactivating various pathogenic viruses (e.g. HIV, HBV, HCV related viruses, HAV, HSV, poliovirus). These experiments proved that pasteurisation effectively inactivates a broad spectrum of viruses with a range of different physicochemical properties. The results, summarized in inactivation kinetics, demonstrate that complete inactivation of high quantities of both enveloped (e.g. HIV, HCV related viruses) and non-enveloped (e.g. poliovirus) viruses takes place during pasteurisation. In clinical trials on the virus safety of plasma derivatives no case of AIDS, hepatitis B or C occurred. From these data we conclude that heat treatment at 60 degrees C in a stabilized aqueous solution confers a high margin of safety on human plasma protein preparations regarding the transmission of diseases such as AIDS or hepatitis.
Nowak
T
T
Microbiology Research Laboratories, Behringwerke AG, Marburg, Germany.
Niedrig
M
M
Bernhardt
D
D
Hilfenhaus
J
J
D001688:Biological Products; D002986:Clinical Trials as Topic; D004340:Drug Contamination / Q000517:prevention & control; D018067:Flaviviridae / Q000502:physiology; D006678:HIV / Q000502:physiology*; D016174:Hepacivirus / Q000502:physiology*; D006515:Hepatitis B virus / Q000502:physiology*; D006358:Hot Temperature; D006801:Humans; D007700:Kinetics; D010849:Picornaviridae / Q000502:physiology; D010949:Plasma / Q000382:microbiology*; D011446:Prospective Studies; D012449:Safety; D014777:Virus Diseases / Q000517:prevention & control; D014779:Virus Replication
D001688:Biological Products