Article(id=1222467107065946775, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1222467099071603148, articleNumber=null, orderNo=null, doi=10.16438/j.0513-4870.2019-0016, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1546444800000, receivedDateStr=2019-01-03, revisedDate=1548432000000, revisedDateStr=2019-01-26, acceptedDate=null, acceptedDateStr=null, onlineDate=1769388470665, onlineDateStr=2026-01-26, pubDate=1562860800000, pubDateStr=2019-07-12, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1769388470665, onlineIssueDateStr=2026-01-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1769388470665, creator=13701087609, updateTime=1769388470665, updator=13701087609, issue=Issue{id=1222467099071603148, tenantId=1146029695717560320, journalId=1189982191388893191, year='2019', volume='54', issue='7', pageStart='1145', pageEnd='1332', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1769388468759, creator=13701087609, updateTime=1769389451859, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1222471222554775860, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1222467099071603148, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1222471222554775861, tenantId=1146029695717560320, journalId=1189982191388893191, issueId=1222467099071603148, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1325, endPage=1329, ext={EN=ArticleExt(id=1222467107623789241, articleId=1222467107065946775, tenantId=1146029695717560320, journalId=1189982191388893191, language=EN, title=Assessment of monoclonality of cell bank for recombinant biologics production, columnId=1208489276405297283, journalTitle=Acta Pharmaceutica Sinica, columnName=New Drug Forum, runingTitle=null, highlight=null, articleAbstract=
To ensure the consistency of quality in recombinant protein production, the cell bank for biologics should be derived from a single clone. A number of techniques have been used for cloning and assurance from the cellular pool after transfection with a target gene. Here, using CHO cell as an example, we summarize the knowledge and understanding of monoclonality of production cell bank from both industries and regulatory authorities, and propose general considerations on the requirements of monoclonality for clinical trial application and new drug application based on current techniques. Furthermore, we suggest quality control strategies and assessment methods for those cell banks from non-single clones.
, correspAuthors=Jian-hui LUO, authorNote=null, correspAuthorsNote=null, copyrightStatement=Copyright ©2019 Acta Pharmaceutica Sinica. All rights reserved., copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Lian-quan QI, Jing ZHAO, Wei WEI, Yu BAI, Jian-hui LUO), CN=ArticleExt(id=1222467108080968411, articleId=1222467107065946775, tenantId=1146029695717560320, journalId=1189982191388893191, language=CN, title=关于重组药物生产用细胞库单克隆性的审评思考, columnId=1208489277814583462, journalTitle=药学学报, columnName=新药论坛, runingTitle=null, highlight=null, articleAbstract=
用于重组蛋白药物生产的细胞库应来源于单个克隆，以保持重组蛋白药物在整个生命周期中质量的一致性。多种技术可用于转染后细胞群的单克隆化分离及确认。本文以CHO细胞为例，综述了工业界和监管机构对于生产用细胞库单克隆性的认知和了解，提出了基于目前技术水平对申报临床及申报上市阶段单克隆性的一般要求，并对非单克隆性来源细胞库的质量控制策略及审评要求提出建议，希望能够为研发机构成功建立重组蛋白药物生产用细胞库提供参考。
, correspAuthors=罗建辉, authorNote=null, correspAuthorsNote=
, copyrightStatement=版权所有©《药学学报》编辑部2019, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=us7bfuF9xXRCDCB0dcMbNA==, magXml=00dQ6Evo/jTlK/BH6prvjg==, pdfUrl=null, pdf=Bzv4jn2if3MOnzSvmz15Kw==, pdfFileSize=453150, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=fk5qeau49u5JoS+KiGeGPg==, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=齐连权, 赵靖, 韦薇, 白玉, 罗建辉)}, authors=[Author(id=1222467108483621624, tenantId=1146029695717560320, journalId=1189982191388893191, articleId=1222467107065946775, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1222467108588479235, tenantId=1146029695717560320, 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