Journal of Food and Drug Analysis (JFDA)
【Update Date:2008-10-06】unit:
Preparation of Hepatitis B Vaccine Reference Standard for Potency Test
CHIA PO LIN,TSO-LING CHEN, RUOH-ING YANG, CHIN-JUNG CHEN AND JUNG-TIAN HSIEH
National Laboratories of Foods and Drugs, Department of Health,Executive Yuan
ABSTRACT
A well qualified plasma derived hepatitis B vaccine, coded 028A, was evaluated in the National Laboratories of Foods and Drugs for its potency to serve as the first national reference standard for hepatitis B vaccine for use in immunogenicity assays. This proposed national reference standard was assayed against the WHO plasma-derived hepatitis B reference standard, lot 96932. The relative potencies of lot 028A plasma-derived hepatitis B vaccine versus WHO lot 96932 vaccine was evaluated in a series of immunization studies for both guinea pig and Balb/c mouse groups by the parallel line assay method.Results obtained indicated that the relative potencies for the guinea pig and mouse groups were 1.04 ± 0.12 and 1.09 ± 0.39, respectively. This reference standard is intended for use in assays of hepatitis B vaccines in both mouse or guinea pig immunogenicity studies for the vaccine sealing tests in Taiwan.
Key words: Hepatitis B Vaccine, Reference Standard, Potency test