Prevnar-13 is a multi-serotype conjugate vaccine directed against pneumococcal disease.  The vaccine is one of the most complex biological products ever approved and has a complex multi-site manufacturing supply chain. The polysaccharide antigens are extracted and purified from each individual microbial serotype following fermentation.  The individual serotype-specific purified polysaccharides are then conjugated to a purified carrier protein in a series of chemical reaction and purification steps carried out at a separate location from the production of the polysaccharides. The final stages of manufacture of the vaccine drug product involves formulation and aseptic filling into vials and syringes.   This presentation will address the challenges involved in bringing this highly successful, high volume biotech product to the market through the lens of the tech transfer process teams charged with implementing a commercial supply platform from this multi-mode supply chain.

Prevnar-13 launch and production network: How many transfers for one product?

243rd National Meeting (2012)

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