DEVELOPMENT OF ELISAS FOR THE QUALITY CONTROL OF A RECOMBINANT PSEUDOMONAS VACCINE

Abstract

Aim. Development and optimization of enzyme immunoassays for quality control of pseudomonas recombinant vaccine. Materials and methods. Recombinant proteins in intermediate products and for completeness of adsorption control were detected in sandwich immunoassay using specific polyclonal and monoclonal antibodies. Detection of the antigen in the vaccine was carried out on the residual amount of antibodies specific to toxoid or OprF that did not bind to the vaccine preparation during the preincubation. Results. ELISAs have been developed and optimized for the quantitative determination of the components (toxoid and membrane protein OprF) of the Pseudomonas recombinant vaccine during the production process. It has been established that: the methods are specific for the determination of toxoid and OprF, the quantitative limit determination has acceptable reliability, the possibility of choosing interpolation of the calibration dependence within the analytical area is shown, the accuracy and precision meets the acceptance criteria, the technique is stable under the conditions of the analysis. Conclusion. Methods can be used to control the quality of the drug during its developing and storage.