VALIDATION OF POTENCY TEST OF IPV COMPONENT IN MULTIVALENT VACCINE MANUFACTURED BY SANOFI PASTEUR

Tóm tắt

According to the World Health Organization (WHO) guidelines, a vaccine's quality control procedure must be validated before it can be used for routine testing. Procedure validation is the process of establishing one or more characteristics, such as accuracy, precision, linearity, linear range, and specificity, to ensure the method's suitability. To quantify the IPV antigen, we fully validated the potency assay procedure for the polio component (IPV) manufactured by Sanofi and used in a combination vaccine. The method used for this quantification was the Enzyme-linked Immunosorbent Assay (ELISA). Within the scope of this paper, we focus on two key validation criteria: specificity and linearity. The results from the validation of the IPV vaccine component showed that the procedure met the requirements for both linearity and specificity. Specifically, the linearity for serotypes 1, 2, and 3 was excellent, with R² values of 0.99, 0.99, and 0.98, respectively.