Ambrosio Ana María, Mariani Mauricio Andrés, Maiza Andrea Soledad, Gamboa Graciela Susana, Fossa Sebastián Edgardo, Bottale Alejando Javier
Instituto Nacional de Enfermedades Virales Humanas, Dr. JI Maiztegui, ANLIS, 2700, Pergamino, Provincia de Buenos Aires, Argentina.
Methods Mol Biol. 2018;1604:305-329. doi: 10.1007/978-1-4939-6981-4_24.
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.
阿根廷出血热（AHF）是一种由胡宁病毒（JUNV）引起的发热性急性疾病，JUNV属于沙粒病毒科。采用完整的活病毒或灭活病毒以及分子构建体来获取预防AHF的有效抗原的不同方法，已处于不同的开发阶段。本章介绍了目前在阿根廷用于预防AHF的JUNV减毒活疫苗株Candid #1。描述了阿根廷国家人类病毒病研究所（位于阿根廷布宜诺斯艾利斯省佩尔加米诺）用于生产源自组织培养的Candid #1疫苗的通用标准化方案。根据阿根廷国家监管机构国家药物、食品和医疗技术管理局（ANMAT）的要求，还分别从生产以及质量控制/质量保证方面介绍了病毒种子和细胞库管理、批量疫苗生产及成品加工等中间阶段。
