Biomaterial Database

Removal and inactivation of hepatitis A virus (HAV) during processing of factor VIII concentrates. 1994

J Hamman, and J Zou, and B Horowitz

New York Blood Center, New York 10021.

Although hepatitis A virus (HAV) transmission by single donor blood products is a rare event, recent reports have raised concerns about the potential for HAV transmission by pooled plasma products. In this study the removal and inactivation of HAV during production of a factor VIII concentrate, which included solvent-detergent treatment and anion-exchange chromatography steps, was assessed at 5 distinct stages of production using infectivity and, in some cases, isotopic assays. The results of these 'spiking' studies revealed an overall HAV clearance of > 8 log with appreciable contributions from antibody neutralisation, cryoprecipitation, lyophilization and possibly chromatography, but not filtration. In addition it was shown that neither solvent detergent treatment or ion-exchange chromatography reversed or impeded the neutralisation of HAV by antibody.

UI	MeSH Term	Description	Entries
D004340	Drug Contamination	The presence of organisms, or any foreign material that makes a drug preparation impure.	Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
D005169	Factor VIII	Factor VIII of blood coagulation. Antihemophilic factor that is part of the factor VIII/von Willebrand factor complex. Factor VIII is produced in the liver and acts in the intrinsic pathway of blood coagulation. It serves as a cofactor in factor X activation and this action is markedly enhanced by small amounts of thrombin.	Coagulation Factor VIII,Factor VIII Clotting Antigen,Factor VIII Coagulant Antigen,Factor VIII Procoagulant Activity,Thromboplastinogen,Blood Coagulation Factor VIII,F VIII-C,Factor 8,Factor 8 C,Factor Eight,Factor VIIIC,Hyate-C,Hyatt-C,F VIII C,Hyate C,HyateC,Hyatt C,HyattC
D006506	Hepatitis A	INFLAMMATION of the LIVER in humans caused by a member of the HEPATOVIRUS genus, HUMAN HEPATITIS A VIRUS. It can be transmitted through fecal contamination of food or water.	Hepatitis, Infectious,Infectious Hepatitis,Hepatitides, Infectious,Infectious Hepatitides
D006507	Hepatovirus	A genus of PICORNAVIRIDAE causing infectious hepatitis naturally in humans and experimentally in other primates. It is transmitted through fecal contamination of food or water. HEPATITIS A VIRUS is the type species.	Hepatitis Virus, Infectious,Infectious Hepatitis Virus,Hepatitis Viruses, Infectious,Hepatoviruses,Infectious Hepatitis Viruses
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D065227	Transfusion Reaction	Complications of BLOOD TRANSFUSION. Included adverse reactions are common allergic and febrile reactions; hemolytic (delayed and acute) reactions; and other non-hemolytic adverse reactions such as infections and adverse immune reactions related to immunocompatibility.	Delayed Hemolytic Transfusion Reaction,Acute Hemolytic Transfusion Reaction,Blood Transfusion-Associated Adverse Reactions,Delayed Serologic Transfusion Reaction,Febrile Non-Hemolytic Transfusion Reaction,Hemolytic Transfusion Reaction,Hypotensive Transfusion Reaction,Post-Transfusion Purpura,Posttransfusion Purpura,TAGHD,Transfusion-Associated Allergic Reaction,Transfusion-Associated Circulatory Overload,Transfusion-Associated Dyspnea,Transfusion-Associated Graft Vs. Host Disease,Transfusion-Transmitted Infection,Allergic Reaction, Transfusion-Associated,Blood Transfusion Associated Adverse Reactions,Circulatory Overload, Transfusion-Associated,Circulatory Overloads, Transfusion-Associated,Dyspnea, Transfusion-Associated,Febrile Non Hemolytic Transfusion Reaction,Hemolytic Transfusion Reactions,Infection, Transfusion-Transmitted,Post Transfusion Purpura,Posttransfusion Purpuras,Purpura, Post-Transfusion,Purpura, Posttransfusion,Reaction, Hemolytic Transfusion,Reaction, Hypotensive Transfusion,Reactions, Hemolytic Transfusion,Transfusion Associated Allergic Reaction,Transfusion Associated Circulatory Overload,Transfusion Associated Dyspnea,Transfusion Associated Graft Vs. Host Disease,Transfusion Reaction, Hemolytic,Transfusion Reaction, Hypotensive,Transfusion Reactions,Transfusion Reactions, Hemolytic,Transfusion Reactions, Hypotensive,Transfusion Transmitted Infection,Transfusion-Associated Circulatory Overloads,Transfusion-Transmitted Infections