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Manufacturing process development for an epidermal growth factor-based cancer vaccine

Abstract:

The Center for Molecular Immunology (Havana, Cuba) has been working on a novel cancer immunotherapy targeting the epidermal growth factor (EGF). The vaccine is composed of a chemical conjugate of EGF and a carrier protein (rP64k), designed to trigger an anti-EGF antibody response. Advanced clinical trials demanded further manufacturing process development to address scale-up and validation limitations in the initial process. The process development strategy focused on replacing the membrane dialysis purification step with a method that could be scaled up more easily; incorporating disposable technology to further facilitate scale-up and cleaning validation; and improving process and product characterization. The consistency of the new process was evaluated, and the equivalence of the vaccine preparations was assessed. The results of studies of molecular characterization, immunogenic activity, and clinical data are presented here.