Biomaterial Database

Inactivation of hepatitis viruses and HIV in plasma and plasma derivatives by treatment with beta-propiolactone/UV irradiation. 1989

W Stephan

Biotest Pharma, Frankfurt/Main, FRG.

A combined treatment of plasma or plasma derivatives by beta-propiolactone (beta-PL)/UV irradiation is in use at Biotest for the preparation of the virus-safe, stabilized serum (Biseko) and coagulation factor concentrates. The efficacy of this sterilization procedure has been demonstrated for HAV (greater than 8.2 log10), HBV (6.9 log10), NANBHV (greater than 4.5 log10) and HIV (greater than 6.0 log10). The methods used in these studies (titration in chimpanzees or cell cultures) are not applicable in routine monitoring of sterilization processes. We therefore developed a test system using four types of bacteriophages: phi X174, phi e, Kappa and f2. Using these bacteriophages in 88 single tests, sterilization efficacy was regularly monitored during the period from 1981 to 1986. The four types of bacteriophages showed, on average, an inactivation rate of 6.7 log10, independent of size or genome structure. This inactivation is in the range of the inactivation of the relevant pathogenic virus, HBV, by beta-PL/UV. It was shown that under the production conditions of Intraglobin and the other Biotest immunoglobulin preparations, beta-PL (without UV) is as virucidal as the combination of beta-PL/UV in plasma or cryo-poor plasma.

UI	MeSH Term	Description	Entries
D007783	Lactones	Cyclic esters of hydroxy carboxylic acids, containing a 1-oxacycloalkan-2-one structure. Large cyclic lactones of over a dozen atoms are MACROLIDES.	Lactone
D010949	Plasma	The residual portion of BLOOD that is left after removal of BLOOD CELLS by CENTRIFUGATION without prior BLOOD COAGULATION.	Blood Plasma,Fresh Frozen Plasma,Blood Plasmas,Fresh Frozen Plasmas,Frozen Plasma, Fresh,Frozen Plasmas, Fresh,Plasma, Blood,Plasma, Fresh Frozen,Plasmas,Plasmas, Blood,Plasmas, Fresh Frozen
D011420	Propiolactone	Disinfectant used in vapor form to sterilize vaccines, grafts, etc. The vapor is very irritating and the liquid form is carcinogenic.	Propanolide,beta-Propiolactone,beta Propiolactone
D001781	Blood Component Removal	Any procedure in which blood is withdrawn from a donor, a portion is separated and retained, at the same time the remainder is returned to the donor.	Apheresis,Pheresis,Aphereses,Blood Component Removals,Phereses,Removal, Blood Component
D005591	Chemical Fractionation	Separation of a mixture in successive stages, each stage removing from the mixture some proportion of one of the substances, for example by differential solubility in water-solvent mixtures. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)	Fractionation, Chemical,Chemical Fractionations,Fractionations, Chemical
D006518	Hepatitis Viruses	Any of the viruses that cause inflammation of the liver. They include both DNA and RNA viruses as well viruses from humans and animals.	Hepatitis Virus, Marmoset,Hepatitis Virus,Hepatitis Viruses, Marmoset,Marmoset Hepatitis Virus,Marmoset Hepatitis Viruses,Virus, Hepatitis,Virus, Marmoset Hepatitis,Viruses, Hepatitis,Viruses, Marmoset Hepatitis
D006678	HIV	Human immunodeficiency virus. A non-taxonomic and historical term referring to any of two species, specifically HIV-1 and/or HIV-2. Prior to 1986, this was called human T-lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV). From 1986-1990, it was an official species called HIV. Since 1991, HIV was no longer considered an official species name; the two species were designated HIV-1 and HIV-2.	AIDS Virus,HTLV-III,Human Immunodeficiency Viruses,Human T-Cell Lymphotropic Virus Type III,Human T-Lymphotropic Virus Type III,LAV-HTLV-III,Lymphadenopathy-Associated Virus,Acquired Immune Deficiency Syndrome Virus,Acquired Immunodeficiency Syndrome Virus,Human Immunodeficiency Virus,Human T Cell Lymphotropic Virus Type III,Human T Lymphotropic Virus Type III,Human T-Cell Leukemia Virus Type III,Immunodeficiency Virus, Human,Immunodeficiency Viruses, Human,Virus, Human Immunodeficiency,Viruses, Human Immunodeficiency,AIDS Viruses,Human T Cell Leukemia Virus Type III,Lymphadenopathy Associated Virus,Lymphadenopathy-Associated Viruses,Virus, AIDS,Virus, Lymphadenopathy-Associated,Viruses, AIDS,Viruses, Lymphadenopathy-Associated
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000818	Animals	Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA.	Animal,Metazoa,Animalia
D013242	Sterilization	The destroying of all forms of life, especially microorganisms, by heat, chemical, or other means.