| Autor: |
Ambrosio AM; Instituto Nacional de Enfermedades Virales Humanas, Dr. JI Maiztegui, ANLIS, 2700, Pergamino, Provincia de Buenos Aires, Argentina. amambrosio@anlis.gov.ar., Mariani MA; Instituto Nacional de Enfermedades Virales Humanas, Dr. JI Maiztegui, ANLIS, 2700, Pergamino, Provincia de Buenos Aires, Argentina., Maiza AS; Instituto Nacional de Enfermedades Virales Humanas, Dr. JI Maiztegui, ANLIS, 2700, Pergamino, Provincia de Buenos Aires, Argentina., Gamboa GS; Instituto Nacional de Enfermedades Virales Humanas, Dr. JI Maiztegui, ANLIS, 2700, Pergamino, Provincia de Buenos Aires, Argentina., Fossa SE; Instituto Nacional de Enfermedades Virales Humanas, Dr. JI Maiztegui, ANLIS, 2700, Pergamino, Provincia de Buenos Aires, Argentina., Bottale AJ; Instituto Nacional de Enfermedades Virales Humanas, Dr. JI Maiztegui, ANLIS, 2700, Pergamino, Provincia de Buenos Aires, Argentina. |
| Abstrakt: |
Argentinian hemorrhagic Fever (AHF) is a febrile, acute disease caused by Junín virus (JUNV), a member of the Arenaviridae. Different approaches to obtain an effective antigen to prevent AHF using complete live or inactivated virus, as well as molecular constructs, have reached diverse development stages. This chapter refers to JUNV live attenuated vaccine strain Candid #1, currently used in Argentina to prevent AHF. A general standardized protocol used at Instituto Nacional de Enfermedades Virales Humanas (Pergamino, Pcia. Buenos Aires, Argentina) to manufacture the tissue culture derived Candid #1 vaccine is described. Intermediate stages like viral seeds and cell culture bank management, bulk vaccine manufacture, and finished product processing are also separately presented in terms of Production and Quality Control/Quality Assurance requirements, under the Adminitracion Nacional de Medicamentos, Alimentos y Tecnología Medica (ANMAT), the Argentine national regulatory authority. |
