Development and Validation of Biochemical Assay for Quality of Vaccine. Method Validation for Vaccine

      Аннотация: Anthrone assay is a recent technique for polysaccharide estimation with several advantages like less interference. To employ this technique as routine quality control test in vaccine industry, validation of this method according to regulatory guidelines was necessary. In present study to validate this method and to generate reliable data, various experiments were designed for execution of different validation parameters.In the present work, the polysaccharide estimation using anthrone reagent has been found quite easier and reproducible. Range of linearity was observed to be 5-125 µg with correlation coefficient 0.999. Anthrone assay for determination of polysaccharide was found to be specific, precise, accurate, robust and stable. Hence it can be employed as routine quality control test for conjugate vaccine products.

Ключевые слова: Athrone Assay, ELISA, biochemical assay, validation, vaccine