The phenomenal success of Pneumococcal and Meningococcal glycoconjugate vaccines has laid a strong foundation for the development of the next generation of candidates in both the bacterial and immunotherapeutic conjugate vaccine areas.  There is a greater emphasis towards the development of sustainable models that address scale-up, control and consistency.  The presence of multiple reaction sites and the carrier proteins in conjunction with the need to preserve potentially critical immunogenic epitopes in the polysaccharides presents special challenges for the conjugation chemistry development. The development challenges for complex multi-valent and multi component vaccines are much greater.  The presentation will discuss examples of using integrated approaches, using Design of Experiments (DOE), Statistical Process Control, process-analytical tools and scale-down models, that could be applied towards a seamless development strategy for multi-valent and multi component vaccines.

Glycoconjugate vaccines: Development challenges

248th National Meeting (2014)

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