ABSTRACT
The production of Pertussis Vaccine was reevaluated at the Instituto Nacional de Higiene(r)Rafael Rangel(r) in order to optimise it in terms of vaccine yield, potency, specific toxicity and efficiency (cost per doses). Four different processes, using two culture media (Cohen-Wheeler and Fermentacion Glutamato Prolina-1) and two types of bioreactors (25 L Fermentador Caracas and a 450 L industrial fermentor) were compared. Runs were started from freeze-dried strains (134 or 509) andcontinued until the obtention of the maximal yield. It was found that the combination Fermentacion Glutamato Prolina-1/industrial fermentor, shortened the process to 40 hours while consistently yielding a vaccine of higher potency (7.91 +/- 2.56 IU/human dose) and lower specific toxicity in a mice bioassay. In addition, the physical aspect of the preparation was rather homogeneous and free of dark aggregates. Most importantly, the biomass yield more than doubled those of the Fermentador Caracas using the two different media and that in the industrial fermentor with the Cohen-Wheeler medium. Therefore, the cost per doses was substantially decreased
Subject(s)
Animals , Mice , Pertussis Vaccine , Bioreactors , Bordetella pertussis/growth & development , Costs and Cost Analysis , Fermentation , Pertussis Vaccine/biosynthesis , Pertussis Vaccine/economicsABSTRACT
O tempo de destoxificaçäo, o rendimento e a potência da vacina Pertussis foram avaliados em cultivos de Bordetella pertussis isentos e adicionados com diferentes concentraçöes de anti-espumante em fermentadores (Biolafitte 50L). Foram realizadas modificaçöes nos fermentadores e no procedimento da fermentaçäo, com a finalidade de evitar a formaçäo de espuma nos cultivos. Suspensöes de B. pertussis com anti-espumante apresentaram maior tempo de destoxificaçäo e menor rendimento quando comparadas com aquelas isentas do agente químico. Em todos os processos, a potência foi superior a 8 UI/ml, estando de acordo com as recomendaçöes da Organizaçäo Mundial da Saúde