Manufacturing

PCVs, in countries where implemented, have been successful in reducing the number of cases of vaccine-type diseases.¹

Prevenar 13® represents a public health success for society worldwide.¹

At Pfizer, we are proud of this achievement and recognise that it could not have happened without a highly experienced team, some of whom have been here for over 20 years,² working closely with healthcare professionals around the world.

Pfizer strives for vaccine supply reliability³ by using a highly integrated and adaptable global manufacturing and distribution network.^2-4

Thousands of dedicated manufacturing colleagues each play their role in bringing every single dose of Prevenar 13® to market and seek to maintain the highest quality standards.

To explain the manufacturing process of Prevenar 13®, we start with the production of the polysaccharides. These are repeated unit of sugars bonded together, present on the surface of the bacterial capsule.

There are 3 main processes: Fermentation, clarification and purification.

First, during the fermentation process, 13 different types of the bacteria S. pneumoniae are grown in production fermenters.

Each of these is a specific strain of the bacteria that expresses a unique polycapsular polysaccharide which has been assigned an individual identification number, referred to as a serotype.

Through clarification and then purification stages, the 13 different polysaccharides essential for Prevenar 13® are produced.

Quality and safety are built into every step of the polysaccharide manufacturing process and includes a variety of tests and checks throughout the process to help ensure consistency in every batch.

The 13 polysaccharides are then stored and are ready for the next stage.

Meanwhile, the carrier protein called CRM₁₉₇ is manufactured. Bacterial cells in vials are grown under controlled conditions in increasing volumes of growth media until the final fermentation step, when the protein is produced by the bacteria. It is then processed through ultra-filtration and column chromatography.

Finally the CRM₁₉₇ is bottled and stored in a frozen state. Automation is utilised throughout the process to ensure each batch is processed the same, assuring high quality standards.

CRM₁₉₇, cross-reactive-material 197; PCV, pneumococcal conjugate vaccine.

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