波谱学杂志 ›› 2015, Vol. 32 ›› Issue (2): 342-353.doi: 10.11938/cjmr20150216
许美凤,方均建,董芳霆,颜贤忠*
收稿日期:
2015-02-16
修回日期:
2015-05-08
出版日期:
2015-06-05
发布日期:
2015-06-05
作者简介:
*通讯联系人:颜贤忠,电话:+86-10-66930305,E-mail:yanxz@proteomics.cn.
基金资助:
The National Science and Technology Major Projects (2014ZX09304311-001, 2012ZX09301003-001-010).
XU Mei-feng,FANG Jun-jian,DONG Fang-ting,YAN Xian-zhong*
Received:
2015-02-16
Revised:
2015-05-08
Online:
2015-06-05
Published:
2015-06-05
About author:
XU Mei-feng (1986-), female, born in Fujian, Master, her research focuses on liquid NMR,
Tel: +86-10-66931443, Fax: +86-10-68246161, E-mail: xumeifeng103@126.com.
*Corresponding author: YAN Xian-zhong, Tel: +86-10-66930305, E-mail:yanxz@proteomics.cn.
Supported by:
The National Science and Technology Major Projects (2014ZX09304311-001, 2012ZX09301003-001-010).
摘要:
建立了基于1H NMR 指纹技术的生物类似药高级结构相似性分析方法,利用相关系数r 和决定系数R2 定量评估生物类似药与其原研药的结构相似度.将该方法应 用在一种分子量为1 620 的抗菌性脂肽达托霉素上,比较了其类似药的活性原料成分(API)、类似药制剂与原研药克必信的高级结构相似性.实验结果显示,3 个达托霉素样品的谱图存在显著差异,表明达托霉素类似药与其原研药在水溶液中存在结构差异.将该方法应用在分子量为145 423 的单克隆抗体药物曲妥珠单抗的高级结构比对上.对1个批次的赫赛汀原研药、4 个批次的类似药的1H NMR 谱进行相似性分析,相关系数r和决定系数R2 的结果显示,曲妥珠单抗的类似药与赫赛汀原研药相似度很高;进一步采用局部相关系数进行谱图分析,得到了曲妥珠单抗类似药与赫赛汀原研药之间的微小差异.研究表明,有效结合NMR 指纹分析技术和统计分析方法,将在生物类似药质量控制中发挥重大的作用.
中图分类号:
许美凤,方均建,董芳霆,颜贤忠*. 基于NMR 指纹谱相关分析的生物类似药高级结构评价[J]. 波谱学杂志, 2015, 32(2): 342-353.
XU Mei-feng,FANG Jun-jian,DONG Fang-ting,YAN Xian-zhong*. Higher Order Structure Assessment of Biosimilars Based on the Correlation of NMR Spectral Fingerprints[J]. Chinese Journal of Magnetic Resonance, 2015, 32(2): 342-353.
[1] Walsh G. Biopharmaceutical benchmarks 2014[J]. Nat Biotech, 2014, 32(10): 992-1 000.[2] European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing monoclonal antibodies-non-clinical and clinical issues[OL]. London: European Medicines Agency; 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf.[3] Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry. Scientific considerations in demonstrating biosimilarity to a reference product[OL]. Rockville: Food and Drug Administration; 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf.[4] Berkowitz S A, Engen J R, Mazzeo J R, et al. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars[J]. Nat Rev Drug Discov, 2012, 11(7): 527-540.[5] Falconer R J, Jackson-Matthews D, Mahler S M. Analytical strategies for assessing comparability of biosimilars[J]. J Chem Technol Biotechnol, 2011, 86(7): 915-922.[6] Federici M, Lubiniecki A, Manikwar P, et al. Analytical lessons learned from selected therapeutic protein drug comparability studies[J]. Biologicals, 2013, 41(3): 131-147.[7] Houde D, Berkowitz S A, Engen J R. The utility of hydrogen/deuterium exchange mass spectrometry in biopharmaceutical comparability studies[J]. J Pharm Sci, 2011, 100(6): 2 071-2 086.[8] Amezcua C A, Szabo C M. Assessment of higher order structure comparability in therapeutic proteins using nuclear magnetic resonance spectroscopy[J]. J Pharm Sci, 2013, 102(6): 1 724-1 733.[9] Wishart D S. Characterization of biopharmaceuticals by NMR spectroscopy[J]. TrAC-Trends Anal Chem, 2013, 48: 96-111.[10] Quinternet M, Starck J P, Delsuc M A, et al. Heteronuclear NMR provides an accurate assessment of therapeutic insulin's quality[J]. J Pharm Biomed Anal, 2013, 78/79: 252-254. [11] Jin X, Kang S, Kwon H, et al. Heteronuclear NMR as a 4-in-1 analytical platform for detecting modification-specific signatures of therapeutic insulin formulations[J]. Anal Chem, 2014, 86(4): 2 050-2 056.[12] Panjwani N, Hodgson D J, Sauve S, et al. Assessment of the effects of pH, formulation and deformulation on the conformation of interferon alpha-2 by NMR[J]. J Pharm Sci, 2010, 99(8): 3 334-3 342.[13] Sauve S, Gingras G, Aubin Y. Assessment of the three-dimensional structure of recombinant protein therapeutics by NMR fingerprinting: demonstration on recombinant human granulocyte macrophage-colony stimulation factor[J]. Biomol NMR Assign, 2008, 2(1): 5-7.[14] Visser J, Feuerstein I, Stangler T, et al. Physicochemical and functional comparability between the proposed biosimilar Rituximab GP2013 and originator Rituximab[J]. Biodrugs, 2013, 27(5): 495-507.[15] Vu B K, Walsh J D, Dimitrov D S, et al. Dynamics of antibody domains studied by solution NMR[J]. Methods Mol Biol, 2009, 525:533-543, xv. [16] Poppe L, Jordan J B, Lawson K, et al. Profiling formulated monoclonal antibodies by 1H NMR spectroscopy[J]. Anal Chem, 2013, 85(20): 9 623-9 629. |
[1] | 赵尚义 王远军. 基于磁共振图像和改进的UNet++模型区分阿尔茨海默症患者和健康人群[J]. 波谱学杂志, 0, (): 0-0. |
[2] | 鲁 晨 董健健 钟 凯. 9.4T下TX模型鼠脑DTI成像研究[J]. 波谱学杂志, 0, (): 0-0. |
[3] | 王 可 张英华 李雨晴 邹定华. 固体核磁共振技术在水泥基材料研究中的应用[J]. 波谱学杂志, 0, (): 0-0. |
[4] | 刘可文 刘紫龙 汪香玉 陈黎 李钊 吴光耀 刘朝阳. 基于级联卷积神经网络的前列腺磁共振图像分类[J]. 波谱学杂志, 0, (): 0-0. |
[5] | 闫 松 屠小青 彭 梅. 光泵抽运3He极化程度监控系统的设计与实现[J]. 波谱学杂志, 0, (): 0-0. |
[6] | 张一鸣 陈志雪 杨晓云. 丁氟螨酯的波谱学数据解析与结构确证[J]. 波谱学杂志, 0, (): 0-0. |
[7] | 王 强 魏树峰 王 铮 杨文晖. 基于粒子群与遗传算法的矩阵式梯度线圈优化设计[J]. 波谱学杂志, 0, (): 0-0. |
[8] | 王佳鑫 冯继文 陈俊飞 王立英 刘朝阳. 魔角旋转固体核磁共振探头中转子的研制[J]. 波谱学杂志, 0, (): 0-0. |
[9] | 赵智慧 刘表兰 闫小双 武帅帅 茹阁英 毛诗珍 冯继文. PSSS50-b-PNIPAM300嵌段共聚物在二元溶剂中自组装的NMR研究[J]. 波谱学杂志, 0, (): 0-0. |
[10] | 刘慧霞, 辛家祥, 魏达秀. 核自旋单重态的制备及其转化效率和寿命的影响因素分析 [J]. 波谱学杂志, 0, (): 0-0. |
[11] | 雷振宇, 梁欣苗#, 雷友义, 杨 丽, 冯继文. 固体核磁共振技术在锂/钠离子电池碳负极中的应用及研究进展 [J]. 波谱学杂志, 0, (): 0-0. |
[12] | 张之杰 李端秀 罗春 仇汝臣 邓宗武 张海禄. 晶体学辅助的2-吡啶甲酸固体13C化学位移理论计算归属[J]. 波谱学杂志, 0, (): 0-0. |
[13] | 包婉静 曾庆琦 余钫 秦蕾 陈智勇. 一种非连续微波探询信号的实现[J]. 波谱学杂志, 0, (): 0-0. |
[14] | 张芬芬 沈文斌 徐开兵 杨 明. 基于定量核磁共振氢谱测定新药替格瑞洛[J]. 波谱学杂志, 0, (): 0-0. |
[15] | 徐广永 董满园 马建锋 张利民.
固体核磁共振研究半晶聚-3-羟基丁酸酯和聚羟基丁酸戊酸酯的分子动力学(英文) [J]. 波谱学杂志, 0, (): 0-0. |
阅读次数 | ||||||
全文 |
|
|||||
摘要 |
|
|||||