Glycoconjugates manufactured by partial oxidation of bacterial polysaccharides and subsequent conjugation via reductive amination to primary amine groups on the carrier protein are heterogeneous with respect to molecular size distribution and structure.  As a result, predicting the effects of changes in raw materials or upstream process steps can be challenging.  Use of a carrier protein manufactured using an improved manufacturing process resulted in an unanticipated decrease in filterability on a subsequent depth filtration step during pneumococcal glycoconjugate vaccine manufacturing.  This presentation describes the application of analytical characterization studies and small-scale process models to understand the behavior of the carrier protein during the conjugation process, to screen for manufacturability issues and to identify adjustments to conjugation process parameters for improved process consistency.

Impact of upstream process changes on glycoconjugate vaccine manufacturing consistency

248th National Meeting (2014)

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