Process development for a Cuban cholera vaccine based on the attenuated strain Vibrio cholerae 638

Area of Science:

• Microbiology
• Vaccinology
• Biotechnology

Background:

• Genetically modified Vibrio cholerae strain 638 (biotype El Tor, serotype Ogawa) has demonstrated immunogenicity in preclinical and clinical studies.
• Development of large-scale production methods is crucial for vaccine accessibility.

Purpose of the Study:

• To describe the process development for producing the 638 attenuated cholera vaccine.
• To ensure the final product maintains key microbiological and immunological properties.

Main Methods:

• Development of cell seed bank, biomass culture, lyophilization, and final formulation processes.
• Analysis of culture kinetics using a logistical model.
• Evaluation of microbiological properties, colonization capability, immunogenicity, and non-toxigenicity.

Main Results:

• Culture kinetics followed a logistical model, indicating predictable growth patterns.
• The final cholera vaccine product was indistinguishable from the working seed lot in key properties.
• The strain demonstrated robustness suitable for large-scale fermentation.

Conclusions:

• The developed processes are suitable for the large-scale production of the 638 attenuated cholera vaccine.
• Strain 638 is non-reactogenic, immunogenic, and protective, making it a viable candidate for widespread use.