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Conjugate Vaccine: Challenges during process development, regulatory aspects and scale-up

Suresh Beri

The challenges in vaccine development are not only to identify the suitable antigen, its efficacy, pre-clinical and clinical evaluation. The late stage developments like process development, regulatory aspects and scale up possess different sets of challenges to commercialize the vaccine. Manufacturing process for conjugate vaccines is very complex and has various biological and chemical steps. The presentation will focus on the design of experiments, critical process parameters for process development and scale up for commercial manufacturing for conjugate vaccines.