Study on Recombinant Hepatitis B Vaccine : Development of ELISA Methods for Detection of Contaminating Yeast Components in the Vaccine and Humoral Anti-yeast Component Antibody Developed in Humans and Guinea-pigs

Open Access
Publisher Website
Google Scholar
Abstract
We have developed an enzyme-linked immunosorbent assay (ELISA) method for the detection of contaminating yeast components in the hepatitis B surface antigen (HBsAg) which was produced using yeast (Saccharomyces cerevisiae) by gene technology. This method could detect ng/ml of the yeast component mixture. By using this method, we found that average remaining amounts of the yeast component mixture in specimens of recombinant HBsAg manufactured in an industrial real were not more than 0.52%, which was verified by the sodiumdodecylsulfate-polyacrylamidde gel electrophoretic method. Next, we have developed an ELISA method for the assay of anti-yeast component antibody and analyzed changes of the antibody level in guinea-pig and human sera after vaccination with recombinant hepatitis B vaccine. Maximum doses given to guinea-pigs and humans were 100 and 20 .mu.g per individual, respectively. As a result, anti-HBs antibody level in guinea-pig and human sera increased after vaccination, but no change was observed in anti-yeast component antibody level.