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Cell substrates for the production of viral vaccines

机译:用于生产病毒疫苗的细胞底物

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Vaccines have been used for centuries to protect people and animals against infectious diseases. For vaccine production, it has become evident that cell culture technology can be considered as a key milestone and has been the result of decades of progress. The development and implementation of cell substrates have permitted massive and safe production of viral vaccines. The demand in new vaccines against emerging viral diseases, the increasing vaccine production volumes, and the stringent safety rules for manufacturing have made cell substrates mandatory viral vaccine producer factories. In this review, we focus on cell substrates for the production of vaccines against human viral diseases. Depending on the nature of the vaccine, choice of the cell substrate is critical. Each manufacturer intending to develop a new vaccine candidate should assess several cell substrates during the early development phase in order to select the most convenient for the application. First, as vaccine safety is quite naturally a central concern of Regulatory Agencies, the cell substrate has to answer the regulatory rules stringency. In addition, the cell substrate has to be competitive in terms of viral-specific production yields and manufacturing costs. No cell substrate, even the so-called "designer" cell lines, is able to fulfil all the requested criteria for all viral vaccines. Therefore, the availability of a variety of cell substrates for vaccine production is essential because it improves the chance to successfully respond to the current and future needs of vaccines linked to new emerging or re-emerging infectious diseases (e.g. pandemic flu, Ebola, and Chikungunya outbreaks). (C) 2015 Elsevier Ltd. All rights reserved.
机译:疫苗已经使用了数百年,以保护人类和动物免受传染病的侵害。对于疫苗的生产,很明显,细胞培养技术可以被视为关键的里程碑,并且是数十年发展的结果。细胞底物的开发和实施已经允许大规模和安全地生产病毒疫苗。对新出现的病毒性疾病的新疫苗的需求,疫苗产量的增加以及严格的生产安全规定已使细胞底物成为病毒疫苗生产厂的强制性要求。在这篇综述中,我们专注于用于生产抗人类病毒性疾病疫苗的细胞基质。根据疫苗的性质,细胞底物的选择至关重要。每个打算开发新疫苗候选者的制造商都应在早期开发阶段评估几种细胞底物,以便选择最方便使用的疫苗。首先,由于疫苗安全性自然是监管机构的主要关注点,因此细胞底物必须应对监管规则的严格性。另外,细胞底物必须在病毒特异性产量和制造成本方面具有竞争力。没有细胞底物,即使是所谓的“设计”细胞系,也无法满足所有病毒疫苗的所有要求标准。因此,提供多种细胞底物用于疫苗生产至关重要,因为它增加了成功应对与新出现或重新出现的传染病(例如大流行性流感,埃博拉和基孔肯雅病)相关的疫苗当前和未来需求的机会爆发)。 (C)2015 Elsevier Ltd.保留所有权利。

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