生物治疗药物和生物类似药的病毒安全性。
Viral safety for biotherapeutics and biosimilar.
机构信息
Charles River Laboratories, Gottfried-Hagen-Street 20, 51105 Cologne, Germany.
出版信息
Drug Discov Today Technol. 2020 Dec;37:23-29. doi: 10.1016/j.ddtec.2020.08.001. Epub 2020 Oct 14.
PMID:34895652
Abstract
This review summarizes the viral safety concepts applied for cell line derived recombinants including biosimilars. The major aspects - material sourcing, testing, and viral clearance - are outlined and essentials per aspect to be considered described in more detail. The principles of viral clearance are explained in more detail like the background of viral removal or inactivation, model virus selection and definition of virus reduction capacity.
摘要
本综述总结了用于细胞系衍生重组药物（包括生物类似药）的病毒安全性概念。概述了主要方面，包括材料来源、检测和病毒清除，并详细描述了每个方面需要考虑的要点。详细解释了病毒清除的原理，例如病毒去除或失活的背景、模型病毒的选择以及病毒减少能力的定义。
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