Development and Qualification of Identity Test for Coronavirus Vaccines

Abstract

The main purpose of the identity test is to ensure that each component shall be tested for conformation for purity, strength, and quality of the drug product. Molecular techniques like Loop-mediated isothermal amplification, Real-time RT-PCR, and Latex agglutination assays are the method for reliable quantification of low-abundance antigen in fill finished drug products. These methods are comparatively quick, specific, sensitive, robust, accurate, and precise to another method. The live-attenuated vaccine contains a live virus that provides a long-lasting immune response. In identity tests, methods are used to check for parameters like suitability, specificity, sensitivity, detection range, accuracy, and robustness. Hypothesis 1. Nucleotides are very specific; they should be able to detect and therefore can be used in identity tests. 2. We’re having monoclonal and polyclonal antibodies which bind to the antigen; these antibodies are specific to spike protein and they should be able to identify Coronavirus. Objective 1. Development of a loop-mediated isothermal amplification method to detection of Coronavirus in Coronavirus vaccine strain. 2. Development of a one-step real-time RT-PCR for detection of Measles, Rubella, and Coronavirus in a combination vaccine. 3. Development of latex bead agglutination assay to detect COVID-19 vaccine strain. VII