{"title":"Viral safety for biotherapeutics and biosimilar","authors":"Horst Ruppach","doi":"10.1016/j.ddtec.2020.08.001","DOIUrl":null,"url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":36012,"journal":{"name":"Drug Discovery Today: Technologies","volume":"37 ","pages":"Pages 23-29"},"PeriodicalIF":0.0000,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ddtec.2020.08.001","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Discovery Today: Technologies","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1740674920300093","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
引用次数: 0
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.
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.
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