Inactivation studies on Japanese Encephalitis Virus Vaccine using Design of Experiments
2006
This poster seeks to use a design of experiments based methodology to investigate viral inactivation step of JEV. The current manufacturing conditions are non-optimal in terms of inactivation time and antigen recovery. Several key variables of the formaldehyde inactivation of JEV have been identified from the literature for investigation: temperature, pH, formaldehyde concentration and the presence of stabilisers (glycerol, sorbitol, lysine, glycine and PEG). As a factor screening experiment, a two level factorial design will be presented involving 36 experimental runs including 4 centre points. The measured effect will be antigen recovery measured by ELISA specific to the vaccine. The data will determine which of the factors are the most significant and which factors contribute to interaction effects with regards to optimal inactivation of JEV for use in a vaccine.
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