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[Optimization of the pertussis vaccine production process]
J Germán Santiago1, N Zamora, E de la Rosa
1División de Producción de Vacunas Bacterianas, Instituto Nacional de Higiene Rafael Rangel, Caracas, Venezuela.
Acta Cientifica Venezolana
|January 1, 1995
Summary
Optimizing Pertussis Vaccine production, a new method using Fermentación Glutamato Prolina-1 medium and an industrial fermentor significantly improved vaccine yield and potency while reducing costs. This enhanced process offers a more efficient and cost-effective approach to Pertussis Vaccine manufacturing.
Area of Science:
- Vaccinology
- Bioprocess Engineering
- Microbial Fermentation
Background:
- Pertussis Vaccine production requires optimization for yield, potency, toxicity, and cost-efficiency.
- Previous methods may not fully leverage advancements in fermentation technology.
Purpose of the Study:
- To reevaluate and optimize the production of Pertussis Vaccine.
- To compare different culture media and bioreactor systems for improved vaccine manufacturing.
Main Methods:
- Four distinct production processes were evaluated.
- Two culture media (Cohen-Wheeler and Fermentación Glutamato Prolina-1) and two bioreactors (25 L Fermentador Caracas and 450 L industrial fermentor) were utilized.
- Production runs started from freeze-dried strains (134 or 509) to maximize yield.
Main Results:
- The Fermentación Glutamato Prolina-1 medium combined with the industrial fermentor shortened the process to 40 hours.
- This combination yielded a vaccine with higher potency (7.91 +/- 2.56 IU/human dose) and lower specific toxicity.
- Biomass yield more than doubled compared to other tested combinations, substantially decreasing the cost per dose.
Conclusions:
- The Fermentación Glutamato Prolina-1 medium and industrial fermentor represent a superior process for Pertussis Vaccine production.
- This optimized method enhances vaccine quality, reduces production time, and significantly lowers manufacturing costs.