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首页> 外文期刊>International journal of infectious diseases : >Best practices in nucleic acid removal from viral vaccine manufacture
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Best practices in nucleic acid removal from viral vaccine manufacture

机译:从病毒疫苗生产中去除核酸的最佳实践

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Background: The production of viral vaccines at commercial scale requires large quantities of viruses as an antigenic source. There are different production platforms suitable for viral replication -mammalian, avian and insect cells. Host cell residuals in the final product - nucleic acid in particular - create a significant concern due to a potential transfer and integration into the living cell's genetic material, potentially leading to various harmful effects including cancer. Health authorities and regulatory bodies continue to increase safety standards for biopharmaceutical products, providing stringent guidelines on removal of residual nucleic acid from the vaccine manufacturing processes.
机译:背景:商业规模生产病毒疫苗需要大量病毒作为抗原源。有适用于病毒复制的不同生产平台-哺乳动物,禽和昆虫细胞。最终产物中的宿主细胞残留物,尤其是核酸,由于可能转移并整合到活细胞的遗传物质中而引起人们的极大关注,潜在地导致包括癌症在内的各种有害影响。卫生当局和监管机构继续提高生物制药产品的安全标准,为从疫苗生产过程中去除残留核酸提供了严格的指导方针。

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