Article(id=1236334087133262451, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334083500995077, 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=1672675200000, acceptedDateStr=2023-01-03, onlineDate=1772694616349, onlineDateStr=2026-03-05, pubDate=1690646400000, pubDateStr=2023-07-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694616349, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694616349, creator=13701087609, updateTime=1772694616349, updator=13701087609, issue=Issue{id=1236334083500995077, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='14', pageStart='1385', pageEnd='1488', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=0, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694615483, creator=13701087609, updateTime=1772696065206, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236340164130295845, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334083500995077, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236340164130295846, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236334083500995077, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1423, endPage=1431, ext={EN=ArticleExt(id=1236334087334589055, articleId=1236334087133262451, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Establishment and validation of a biological activity detection method for adalimumab, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To establish a method for determining the biological activity of adalimumab based on tumor necrosis factor-α (TNF-α) neutralization activity to provide technical means for parallel comparison of biological activities of similar biotherapeutic products of adalimumab.
Methods: The mouse fibroblast cell line L929 was used as target cell and the key reagents such as TNF-α and actinomycin D (Act-D) were standardized, then the experiment parameters including cell inoculation density, concentrations of key reagents, dilution gradient of adalimumab and incubation time were optimized. Then, the optimized method was validated by the methodology verification in the laboratory and the joint validation between laboratories to evaluate the performance of the method and its applicability to adalimumab reference products and similar biotherapeutic products.
Results: There was a dose-response relationship between adalimumab concentrations and signal values in this method. The optimized concentrations of TNF-α and Act-D were 1 ng·mL-1 and 400 ng·mL-1 respectively, the optimized seeded cell number was 2×104 cells per well, the optimized initial antibody concentration was 1 000 ng·mL-1, the dilution ratio was 1∶2.5, and the optimized seeding time and incubation time were 18 h and 24 h. Methodological validation showed that this method was specific, reproducible and accurate. The results of joint validation were satisfactory.
Conclusion: This method is applicable to the five listed adalimumab products and can be used as a platform quality control method for the biological activity of adalimumab, which is convenient for the national sampling work and the parallel comparison between the products. It also provides an optional evaluation method for the establishment of national adalimumab standards and technical support for the inclusion of adalimumab monograph in Chinese Pharmacopoeia in the future.
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目的： 建立基于肿瘤坏死因子-α（TNF-α）中和活性测定法的阿达木单抗生物学活性检测方法，为实现阿达木单抗同类产品生物学活性的平行比对研究提供技术手段。
方法： 以小鼠成纤维细胞L929为实验细胞，对TNF-α和放线菌素D（Act-D）等关键试剂进行标准化，并通过摸索细胞接种量、关键试剂浓度、阿达木单抗稀释梯度、孵育时间等对方法进行优化，并对优化后的方法进行实验室内的方法学验证与实验室间的联合验证，证实该方法的性能表现及对阿达木单抗原研药和生物类似药的适用性。
结果： 阿达木单抗在该方法中存在量效关系，优化后的方法确定细胞密度为2×104个·孔-1、TNF-α和Act-D浓度分别为1和400 ng·mL-1、抗体起始浓度为1 000 ng·mL-1、稀释比为1∶2.5、铺板时间和孵育时间为18和24 h，方法学验证表明该方法专属性合理、精密度好、准确性高，联合验证结果满意。
结论： 该方法适用于目前已上市的5家阿达木单抗，可以作为阿达木单抗生物学活性的平台化质控方法，便于国家药品抽验工作开展及各产品间的平行比较，同时也为国家标准品建立提供了可选的评价手段，为未来《中华人民共和国药典》对阿达木单抗各论的收载提供了技术支撑。
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1School of Pharmacy, Yantai University, Yantai 264005, China
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1烟台大学药学院，烟台 264005
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郭莎，女，副研究员，主要从事单克隆抗体质量控制研究。E-mail: guosha@nifdc.org.cn。
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郭莎，女，副研究员，主要从事单克隆抗体质量控制研究。E-mail: guosha@nifdc.org.cn。
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2中国食品药品检定研究院单克隆抗体产品室，国家卫生健康委员会生物技术产品检定方法及标准化重点实验室，国家药品监督管理局生物制品质量研究与评价重点实验室，北京 102629, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236334087837905568, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236334087133262451, xref=2, ext=[AuthorCompanyExt(id=1236334087846294177, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236334087133262451, companyId=1236334087837905568, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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2中国食品药品检定研究院单克隆抗体产品室，国家卫生健康委员会生物技术产品检定方法及标准化重点实验室，国家药品监督管理局生物制品质量研究与评价重点实验室，北京 102629)])]), Author(id=1236334088810984166, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236334087133262451, orderNo=3, 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=1236334088911647475, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236334087133262451, authorId=1236334088810984166, language=EN, stringName=Ya-lan YANG, firstName=Ya-lan, middleName=null, lastName=YANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2中国食品药品检定研究院单克隆抗体产品室，国家卫生健康委员会生物技术产品检定方法及标准化重点实验室，国家药品监督管理局生物制品质量研究与评价重点实验室，北京 102629)])]), Author(id=1236334089150722811, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236334087133262451, orderNo=4, 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=1236334089272357636, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236334087133262451, authorId=1236334089150722811, language=EN, stringName=Cai-feng LONG, firstName=Cai-feng, middleName=null, lastName=LONG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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