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Case study: Purification of Group C meningococcal polysaccharide for a conjugate vaccine

Shwu-Maan Lee, Director, Technical Affairs, Baxter BioScience joined us at the World Vaccine Congress in Washington 2012 to give details on the Group c meningococcal polysaccharide for a conjugate vaccine.
In 2000, the NeisVac-C was licensed in 38 countries and had been introduced in the UK. This prophylactic vaccine prevents the invasive disease caused by the N. meningitidis serogroup C.  Bacterial meningitis causes death in 10% of cases and serious injury in another 15%. This vaccine has many competitive advantages, for example, it is more immunogenic and has an excellent stability profile with 42 months at 5°C and 9 months at 25°C, making it easier to store.

There are 6 key process stages to the production of NeisVac-C:
1. Fermentation
2. Harvest
3. Purification of high molecular weight (MW) polysaccharide
4. Partial depolymerization
5. Sizing
6. Conjugation to TT carrier protein

Stage 3 of this process (Purification of high molecular weight (MW) polysaccharide) is a two phase process within itself, and involves the GCMP isolation from culture supernatant, the De-O-acetylation, dialysis and lyophilisation, gel filtration column chromatography and another round og dialysis and lyophilisation.

Download the full case study to understand the Purification of Group C meningococcal polysaccharide for a conjugate vaccine:
• Purification of high molecular weight polysaccharide by a traditional process for phase I clinical trials
• Development of scalable and robust commercial polysaccharide purification process
• Lessons learned from 10 years of manufacturing experience

 

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