NR AERZ
AU Goldsmith,J.C.
TI Pasteurized, monoclonal antibody factor VIII concentrate: establishing a new standard for purity and viral safety of plasma-derived concentrates.
QU Blood Coagulation and Fibrinolysis 2000 Mar; 11(2): 203-15
PT journal article; review; review, tutorial
AB A factor VIII concentrate (Monoclate-P) manufactured using a combination of pasteurization and immunoaffinity chromatography has been chosen to compare and contrast manufacturing aspects of plasma-derived factor VIII concentrates. Pasteurization is a virucidal method with a long safety record in clinical practice, while immuno-affinity chromatography selectively isolates and purifies the procoagulant protein of factor VIII, and partitions potential viral contaminants and nonessential proteins to the unbound fraction. The complete Monoclate-P production process reduces human immunodeficiency virus by > or = 10.5 log10, Sindbis (a model for hepatitis C virus) by > or = 6.5 log10, and murine encephalomyocarditis virus (a non-enveloped model virus) by 7.1 log10. The viral safety of Monoclate-P has been further demonstrated in clinical studies in patients not previously treated with blood or plasma-derived products. Additionally, the manufacture of Monoclate-P includes careful donor screening and plasma testing for antibodies to syphilis and human immunodeficiency, hepatitis B, and hepatitis C viruses to enhance source plasma safety. Combined with donor selection and plasma testing, multiple viral reduction steps effectively eliminate both lipid-enveloped viruses (e.g. human immunodeficiency, hepatitis B and C) and non-lipid-enveloped viruses (e.g. hepatitis A). In addition, polymerase chain reaction-based nucleic acid detection tests for hepatitis B and C viruses and for human immunodeficiency virus-1 have been introduced as part of an investigational new drug mechanism.
ZR 95
MH *Antibodies, Monoclonal; Chromatography, Affinity/methods; Consumer Product Safety; Creutzfeldt-Jakob Syndrome/virology; Disinfection/methods/standards; Factor VIII/*immunology/*standards; HIV; Hepatitis Viruses; Human; Parvovirus B19, Human; Plasma/virology; Quality Control; Tissue Donors
AD Centeon L.L.C., King of Prussia, Pennsylvania 19406, USA
SP englisch
PO England