組換え B 型肝炎ワクチンの開発研究.ELISA 法による混在酵母成分及び体液性抗酵母成分抗体測定系の開発

概要

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We have developed an enzyme-linked immunosorbent assay (ELISA) method for the detection of contaminating yeast components in the hepatitis B surface antigen (HB_sA_g) which was produced using yeast (Saccharomyces cerevisiae) by gene technology. This method could detect 1 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 HB_sA_g manufactured in an industrial real were not more than 0.52%, which was verified by the sodiumdodecylsulfate-polyacrylamide 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 hapatitis B vaccine. Maximum doses given to guinea-pigs and humans were 100 and 20 μg per individual, respectively. As a result, anti-HB_s antibody level in guinea-pig and human sera increased after vaccination, but no change was observed in anti-yeast component antibody level.
公益社団法人日本薬学会の論文
1988-04-25