In support of vaccine development, we develop, optimize, and validate assays to monitor immunogenicity of candidate vaccines. In addition, we maintain good laboratory practices to assure data consistency and accuracy in support of regulatory filings. In order to have the most relevant assays of immunogenicity, we continually develop, optimize, and validate new assays to monitor vaccine immunogenicity of vaccines, and develop and institute immunogenicity criteria for vaccine lot release by establishing lot release criteria in animal vaccination studies.