Article(id=1322906838680863719, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887806737825858, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1629734400000, acceptedDateStr=2021-08-24, onlineDate=1793335168761, onlineDateStr=2026-10-30, pubDate=1634227200000, pubDateStr=2021-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335168761, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335168761, creator=13701087609, updateTime=1793335168761, updator=13701087609, issue=Issue{id=1322887806737825858, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='19', pageStart='1729', pageEnd='1824', issueExtLink='null', onlineDate='null', pubDate='1634227200000', pubDateStr='2021-10-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793330631192, creator='13701087609', updateTime=1793337389212, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916151994495727, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887806737825858, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916151994495728, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322887806737825858, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1738, endPage=1745, ext={EN=ArticleExt(id=1322906838861218792, articleId=1322906838680863719, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Quality study of recombinant anti-interleukin-23 monoclonal antibodies, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To develop quality control methods for recombinant anti-interleukin-23 monoclonal antibodies (anti-IL23 mAb).
Methods: Peptide map analysis by RP-HPLC was used for identification of an anti-IL-23 mAb. The purity was measured by reduced/non-reduced capillary electrophoresis-sodium dodecyl sulfonate (CE-SDS) and size exclusion-high performance liquid chromatography (SEC-HPLC). Charge heterogeneity was measured by imaging capillary isoelectric focusing electrophoresis (icIEF). LC isoAsp95 was measured by RP-HPLC. The biological activity was determined on U2OS IL23R/IL12RB1 dimerization cell. Other quality control items complied with corresponding requirements of “Chinese Pharmacopeia” 2015 edition and related guidelines.
Results: Peptide mapping showed the specific spectrum of the anti-IL23 mAb, which could be adopted for the identification test. The area percentage of heavy chain, NGHC and light chain was (97.84±0.12)% as detected by reduced CE-SDS; the area percentage of main peak detected by non-reduced CE-SDS was (97.23±0.11)%. The area percentage of monomer peak and total aggregate peak detected by SEC-HPLC were (99.26±0.005)% and (0.71±0.005)%, respectively. The area percentage of main peak, acid peak and alkaline peak detected by icIEF were (73.83±0.29)%, (24.03±0.34)% and (2.10±0.09)%, respectively. The percentage of LC isoAsp95 was (3.37±0.52)%. The relative biological activity was (102.25±8.47)%.
Conclusion: A series of quality control methods for anti-IL23 mAbs has been established, which can be adaptable in ensuring the safety, effectiveness and quality controllability for similar biologics. The study is of great significance as a representative quality control reference for anti-IL23 mAbs.
, authors=Zhi-hao FU, Gang WU, Meng LI, Yong-fei CUI, Lan WANG, authorsList=Zhi-hao FU, Gang WU, Meng LI, Yong-fei CUI, Lan WANG, authorCompany=null, correspAuthors=Lan WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, 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, fund=null), CN=ArticleExt(id=1322906839196763113, articleId=1322906838680863719, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=重组抗白细胞介素23单克隆抗体的质量研究, columnId=1236330552693944345, journalTitle=中国新药杂志, columnName=生物医药前沿, runingTitle=null, highlight=null, articleAbstract=
目的： 针对白细胞介素-23单克隆抗体（抗IL-23单抗）的关键质量属性建立质控方法。
方法： 采用基于反向高效液相色谱法（RP-HPLC）的肽图法进行鉴别；采用还原/非还原十二烷基磺酸钠毛细管电泳（CE-SDS）和分子排阻色谱（SEC-HPLC）进行纯度控制；采用成像毛细管等电聚焦电泳（icIEF）测定电荷异质性；采用RP-HPLC测定轻链95位天冬氨酸异构体（light chain isoAsp95，LC isoAsp95）；采用基于U2OS IL23R/IL12RB1二聚化分析细胞的化学发光法测定生物学活性。其他各项指标均应符合《中华人民共和国药典》2015年版以及其他相关要求。
结果： 肽图检测具有特征图谱，起到很好的鉴别作用。还原CE-SDS的重链、非糖基化重链（nonglycosylated heavy chain，NGHC）和轻链峰面积之和百分比为（97.84±0.12）%，非还原CE-SDS主峰峰面积百分比为（97.23±0.11）%；SEC-HPLC单体的峰面积百分比为（99.26±0.005）%，总聚集体峰面积百分比为（0.71±0.005）%。icIEF分析的主峰的峰面积百分比为（73.83±0.29）%，酸性峰的峰面积百分比为（24.03±0.34）%，碱性峰的峰面积百分比为（2.10±0.09）%；供试品LC isoAsp95的百分比为（3.37±0.52）%；供试品相对于参比品的相对生物学活性为（102.25±8.47）%。
结论： 针对抗IL-23单抗的质量属性，研究建立质控方法并进行质量研究，确保产品的安全有效且质量可控，对抗IL-23单抗的质量控制具有借鉴意义。
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付志浩，男，副研究员，主要从事单克隆抗体质量控制研究。E-mail：fuzhihao@nifdc.org.cn。
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