生物治疗药物和生物仿制药的病毒安全性

Q1 Pharmacology, Toxicology and Pharmaceutics Drug Discovery Today: Technologies Pub Date : 2020-12-01 DOI:10.1016/j.ddtec.2020.08.001

Horst Ruppach

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摘要

本文综述了包括生物仿制药在内的细胞系衍生重组物的病毒安全性概念。主要方面——材料采购、测试和病毒清除——被概述，每个方面的要点被更详细地描述。更详细地解释了病毒清除的原理，如病毒去除或灭活的背景，模型病毒的选择和病毒还原能力的定义。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Viral safety for biotherapeutics and biosimilar

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.

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Drug Discovery Today: Technologies Pharmacology, Toxicology and Pharmaceutics-Drug Discovery

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期刊介绍： Discovery Today: Technologies compares different technological tools and techniques used from the discovery of new drug targets through to the launch of new medicines.