A novel high throughput plate-based method for 2-PE quantification in novel multidose vaccines (R21 malaria,...

Multidose presentation of vaccines is the most preferred choice, for mass immunization particularly during pandemics. WHO also recommends multidose containers of fill finished vaccines for programmatic suitability and global immunizations programmes. However, multidose vaccine presentations requires inclusion of preservatives to prevent contaminations. 2-Phenoxy ethanol (2-PE) is one such preservative which is being used in numerous cosmetics and many vaccines recently. Estimation of 2-PE content in multidose vials is a crucial quality control parameter to ensure in use stability of the vaccines. Presently available conventional methods, have their own limitation in terms of being time consuming, requiring sample extraction, large sample volume requirement etc. Therefore, a robust, simple, high-throughput method with a low turnaround time was required, which can quantitate 2-PE content in the conventional combination vaccines as well as new generation complex VLP based vaccines. In order to address this issue, a novel absorbance-based method has been developed. This novel method specifically detects 2-PE content in Matrix M1 adjuvanted R21 malaria vaccine, nano particle and viral vector based covid vaccines and combination vaccines like Hexavalent vaccine. The method has been validated for parameters such as linearity, accuracy and precision. Importantly, this method works even in presence of high amounts of proteins and residual DNA. Considering the advantages associated with method under study, this method can be used as an important in process or release quality parameter to estimate the 2-PE content in various vaccines containing 2-PE in multidose presentations.