versión On-line ISSN 1025-0298
DEL PUERTO, Carmen A et al. Seed Lot Systems of the Vibrio cholerae 638 vaccinal strain. Vaccimonitor [online]. 2004, vol.13, n.1, pp. 21-28. ISSN 1025-0298.
In the production of biologicals, specially those obtained from microorganisms, it is essential to have a provision of stable, well-characterized cells as a production source. The concept of Seed Lot System in two levels, in which the Master Seed Lot is used to obtain the Working Seed Lot, is considered the most practical approach to achieve this purpose. In this study we developed the Reference and Working Seed Lots of the vaccine strain Vibrio cholerae 638, first stage in the production of a vaccine against cholera complying with the requirements of Good Manufacturing Practices (GMP) demanded by the national and international regulatory authorities. The characterization of the lots demonstrated that adequate levels of viability were achieved. Identity, purity, lack of virulence, ability to colonize the small intestine of suckling mice and to induce an immune response, remained unchanged as in the original strain.
Palabras llave : Seed Lot; Vibrio cholerae; attenuated strain.