Distribution of hepatitis A antibody over a process for the preparation of a high-purity factor VIII concentrate.
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 It was found that the current high-purity factor VIII product has no detectable hepatitis A antibody, whereas the superseded intermediate-purity product had significant antibody levels (6,700 mIU/ml).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.
Hart
H
H
Protein Fractionation Centre, Scottish National Blood Transfusion Service, Edinburgh, UK.
Jones
A
A
Cubie
H
H
McIntosh
R V
RV
Cuthbertson
B
B
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
D006508:Hepatitis Antibodies; D005169:Factor VIII