EVALUATION THE SUITABILITY OF BHK-21 CELL (ATCC) ESTABLISHED AT NATIONAL INSTITUTE FOR CONTROL OF VACCINES AND BIOLOGICALS IN JAPANESES ENCEPHALITIS POTENCY TEST

Abstract

BHK-21 cell is isolated from Syria hamster that has been used widly in many fields such as research, manufacture and quality control of vaccines and biological products. In National Institute for Control of Vaccines and Biologicals (NICVB), the Japanese origined BHK-21 cell bank has been appliedin potency test to evaluate the quality of inactivated Japanese encephalitis (JE) vaccine Jevax, however, the amount of the cell is about 10 vials. Therefore, it is necessary to establish, store and appraise the suitability of BHK-21 cell line from ATCC (American Type Culture Collection) code CCL-10 in JE vaccine potency test with a purpose of replacing the old BHK-21 cell line. By Plaque Reduction Neutralization Test (PRNT₅₀) method, the results showed that BHK-21 cell (ATCC) was sensitive with JE virus and can be applied in JE potency test after optimmized procedure such as changing the cultivation time, observation result after 3 days of infection and changing of challenging virus concentration. The value of potency for samples was in the range of 1,53 to 1,62 log PRNT₅₀. The coefficiency of variations (CV) between samples and reference standard of both 2 cell lines were from 1,01 to 1,04 and had no significant difference. Therefore, BHK-21 (ATCC) cell was suitable and can be applied in potency test of Japanese encephalitis vaccine.