COMPARISON OF MONOCLONAL ANTIBODIES AND POLYCLONALE ANTISERA FOR USE IN A VACCINE DEVELOPMENT AND PRODUCTION QC IMMUNE NEPHELOMETRIC METHOD.
SSI Diagnostica manufactures polyclonal pneumococcus antisera, which is used by vaccine manufacturers in their QC. In this comparing assay we investigate the immunological differences between the monoclonal antibodies and polyclonal antisera using the IMMAGE 800 Immunochemistry System, Beckman Coulter.
Monoclonal and polyclonal antibodies against the 23-valent vaccine serotypes were evaluated in the routine Immunochemistry QC analysis (IMMAGE 800).
Affinity were analysed using specific polysaccharides from ATCC performing standard curves from 0.5 to 5µg/mL. Specificity were analysed using an antigen pool containing 50µg/mL of each of the 23 valent vaccine serotypes from ATCC.
Monoclonal and Polyclonal antisera against serotype 1, 3, 5, 9V and 19A were evaluated undiluted and diluted. The monoclonal antibodies are overall lacking affinity (instrument response) compared with polyclonal antisera, which made it difficult to make an acceptable standard curve giving trouble passing the QC accept criteria set by vaccine manufactures.
Additional data for specificity and the last 18 antibodies will follow on the poster if abstracts is accepted.
The comparison between the pneumococcus monoclonal antibodies and polyclonal antisera, revealed that there is a detectable immunological difference and affinity between the polyclonal pneumococcal sera and the monoclonal pneumococcal sera analyzed in the immune nephelometric assays.