VALIDATION OF POTENCY TEST OF MEASLES COMPONENT IN VACCINE MMRII BY CCID50 METHOD

Abstract

Measles is one of the respiratory infectious diseases caused by virus that can be prevented by vaccination. Validation of effective and safety vaccine before market distribution is an important function of National Institute for Control of Vaccine and Biologicals (NICVB). Therefore, research team validated and evaluated procedure of potency test for measles component in trivalent vaccine MMR^II (MSD) with accurancy, precision, robustness and specifictity indicators. Validation method of potency test is used for measles component in trivalent vaccine MMR^II (MSD) by Cell Culture Infectious Dose 50 (CCID₅₀) that based on SOP KDQG-34: Standard procedure for full validation of NICVB . Potency test of measles component in trivalent vaccine MMR^II by CCID₅₀ method was evaluated with accurancy, precision, robustness and specifictity indicators. Potency results of standard and testing samples were in the allowed range with Coefficient of Variation CV ≤ 25%. Procedure of potency test for measles component in trivalent vaccine MMR^II by CCID₅₀ method gives reliable results and is suitable with condition, chemicals and facility of Department of Quality control of Viral vaccine and it can be applied for routine potency test in National Institute for Control of Vaccines and Biologicals (NICVB).