Routine testing of vaccines and other biologics to ensure efficacy and safety requires large numbers of animals, many of which experience pain and distress during testing. Therefore, identification of methods that would reduce or eliminate the need for animal testing for vaccines is a high priority for different organizations.
KYMOS develops ELISA methods for vaccines from the scratch or by adapting existing commercial kits. By one hand Relevant Antigen Quantification using an ELISA sandwich of monoclonal antibodies allows to obtain an absolute measurement of the relevant antigen in the drug substance or in the drug product. By the other hand In Vitro Antigen Potency Determination using an inhibition ELISA assay is useful to compare the immunological potency of the test antigen versus the immunological potency of a reference antigen.
Once validated, the method can be easily transferred to client’s Quality Control laboratory. If requested, Kymos can provide regular Quality Control testing under GMP for batch release.
