title: Distribution of hepatitis A antibody over a process for the preparation of a high-purity factor VIII concentrate.
abstract: The levels of hepatitis A antibody were studied in factor VIII products manufactured by the Scottish National Blood Transfusion Service. It was found that the current high-purity factor VIII product has no detectable hepatitis A antibody, whereas the superseded intermediate-purity product had significant antibody levels (6,700 mIU/ml). Although the finished high-potency factor VIII product has no detectable hepatitis A antibody, significant levels of antibody are found in the early stages of product manufacture. This antibody may offer some protection against hepatitis A contamination present in very occasional plasma donations. Antibody to parvovirus B19 is also present at intermediate stages in the manufacture of high-potency factor VIII, but its significance is not known. Hepatitis A antibody levels were also measured in normal immunoglobulin. These data indicate that antibody levels in the plasma pools used to manufacture factor VIII are falling.
authors.affiliation: Protein Fractionation Centre, Scottish National Blood Transfusion Service, Edinburgh, UK.
authors.forename: H
authors.initials: H
authors.lastname: Hart
authors.forename: A
authors.initials: A
authors.lastname: Jones
authors.forename: H
authors.initials: H
authors.lastname: Cubie
authors.forename: R V
authors.initials: RV
authors.lastname: McIntosh
authors.forename: B
authors.initials: B
authors.lastname: Cuthbertson
mesh_terms: D003257:Consumer Product Safety; D005169:Factor VIII / Q000302:isolation & purification; D006508:Hepatitis Antibodies / Q000097:blood*; D006507:Hepatovirus / Q000276:immunology*; D006801:Humans; D010949:Plasma / Q000382:microbiology; D012606:Scotland
chemical_list: D006508:Hepatitis Antibodies; D005169:Factor VIII