| 综述 |
|
|
|
|
| 长效化融合蛋白药物及其药动学分析技术的研究进展 |
| 邵莉1, 马晓慧2, 王相阳2, 徐寒梅1 |
1 中国药科大学 南京 211100;
2 天士力制药集团股份有限公司研究院药理毒理研究中心 天津 300410 |
|
| Progression of the Long-term Mechanism and Pharmacokinetics Analysis Technology of Fusion Protein Drugs |
| SHAO Li1, MA Xiao-hui2, WANG Xiang-yang2, XU Han-mei1 |
1 China Pharmaceutical University, Nanjing 211100, China;
2 Division of Pharmacology and Toxicology, Tasly Academy, Tianjin 300410, China |
引用本文:
邵莉, 马晓慧, 王相阳, 徐寒梅. 长效化融合蛋白药物及其药动学分析技术的研究进展[J]. 中国生物工程杂志, 2017, 37(4): 83-88.
SHAO Li, MA Xiao-hui, WANG Xiang-yang, XU Han-mei. Progression of the Long-term Mechanism and Pharmacokinetics Analysis Technology of Fusion Protein Drugs. China Biotechnology, 2017, 37(4): 83-88.
链接本文:
https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.20170411
或
https://manu60.magtech.com.cn/biotech/CN/Y2017/V37/I4/83
|
[1] William R.Fusion proteins for half-life extension of biologics as a strategy to make biobetter. BioDrugs,2015,29(4):215-239.
[2] Caliceti P,Veronese F M.Pharmacokinetic and biodistribution properties of poly(ethylene glycol)-protein conjugates.Adv Drug Delivery Rev,2003,55(10):1261-1277.
[3] Jevsˇevar S,Kunstelj M,Porekar V G.PEGylation of therapeutic proteins.Biotechnol J,2010,5(1):113-128.
[4] Tang L, Persky A M,Hochhaus G,et al.Pharmacokinetic aspects of biotechnology products. J Pharm Sci,2004,93(9):2184-2204.
[5] Andersen J T,Pehrson R,Tolmachev V,et al.Extending half-life by indirect targeting of the neonatal Fc receptor (FcRn) using a minimal albumin binding domain.J Biol Chem, 2011,286(7):5234-5241.
[6] O'Connor-Semmes R L,Lin J,Hodge R J,et al.GSK2374697, a novel albumin-binding domain antibody (albudAb),extends systemic exposure of extendin-4:first study in humans-PK/PD and safety.Clin Pharmacol Ther,2014,96(6):704-712.
[7] Sockolosky J T, Kivimäe S, Szoka F C.Fusion of a short peptide that binds immunoglobulin G to a recombinant protein substantially increases its plasma half-life in mice. PLoS One,2014,9(7):e102566.
[8] Pasut G,Veronese F M.Second-generation pharmaceutical proteins-EUFEPS workshop on optimizing biotech medicines.IDrugs,2007,10(3):162-164.
[9] Bendele A,Seely J, Richey C, et al. Short communication:renal tubular vacuolation in animals treated with polyethylene-glycolconjugated proteins.Toxicol Sci, 1998, 42(2):152-157.
[10] Keizer R J,Huitema A D,Schellens J H,et al.Clinical pharmacokinetics of therapeutic monoclonal antibodies.Clin Pharmacokinet,2010,49(8):493-507.
[11] Ghetie V,Ward E S.Transcytosis and catabolism of antibody.Immunol Res,2002,25(2):97-113.
[12] Peters J T.All about Albumin:Biochemistry,Genetics,and Medical Applications.California:Academic Press,1995.
[13] Roopenian D C,Akilesh S.FcRn:the neonatal Fc receptor comes of age.Nature Rev Immunol,2007,7(9):715-725.
[14] Baker K,Qiao S W,Kuo T, et al. Immune and non-immune functions of the (not so) neonatal Fc receptor, FcRn. Semin Immunopathol,2009,31(2):223-226.
[15] Kagan L,Turner M R,Balu-Iyer S V,et al.Subcutaneous absorption of monoclonal antibodies:Role of dose,site of injection,and injection volume on rituximab pharmacokinetics in rats.Pharm Res,2012,29(2):490-499.
[16] Kagan L,Mager D E.Mechanisms of subcutaneous absorption of rituximab in rats.Drug Metab Dispos,2013,41(1):248-255.
[17] Ledger,Tucker I G,Walker G F.The metabolic barrier of the lower intestinal tract of salmon to the oral delivery of protein and peptidedrugs.Journal of Controlled Release,2002,85(1-3):91-103.
[18] 周治东,李维娜,王存,等.GFE-1多肽与重组人肿瘤坏死因子α融合蛋白的构建及其体外活性和体内分布研究.生物技术通讯,2013,24(2):178. Zhou Z Z,Li W N,Zhang C,et al.Construction,bioactivity and distribution of GFE-1-rmhTNF fusion protein.Letters in Biotechnology,2013; 24(2):178.
[19] Liu S.Radiolabeled cyclic RGD peptides as integrin αvβ3-targeted radiotracers:maximizing binding affinity via bivalency.Bioconjug Chem,2009,20(20):2199.
[20] 郭建军,王丽丽,张琪,等.单克隆抗体药物的药代动力学研究进展,中国药理学通报,2016,32(2):172-176. Guo J J,Wang L L,Zhang Q,et al.Progress on pharmacokinetic studies of therapeutic monoclonal antibodies.Chinese Pharmacological Bulletin,2016,32(2):172-176.
[21] Luu K T,Bergqvist S,Chen E,et al.A model-based approach to predicting the human pharmacokinetics of a monoclonal antibody exhibiting taret-mediated drug disposition.J Pharmacol ExpTher,2012,341(3):702.
[22] Hall M P, Gegg C, Walker K, et al. Ligand-binding mass spectrometry to study biotransformation of fusion protein drugs and guide immunoassay development:Strategic approach and application to peptibodies targeting the thrombopoietin receptor.AAPS J,2010, 12(4):576-585.
[23] Yin H H,Zhu Y Y,Xu L G,et al.Ultrasensitive detection of melamine based on a DNA-labeled immunosensor.Biosens Bioelectron,2013,42(1):51.
[24] Robert E M,Arvind G K.Combined use of immunoassay and two dimensional liquid chromatography mass spectrometry for the detection and identification of metabolites from biotherapeutic pharmacokinetic samples.J Pharmaceut Biomed,2010,53(3):221.
[25] 汪晨,吴洁,宗晨,等.化学发光免疫分析方法与应用进展.分析化学,2012,40(1):3-10. Wang C,Wu J,Zong C,et al. Chemiluminescent immunoassay and its application. Chinese Journal of Analytical Chemistry, 2012,40(1):3-10.
[26] 农天雷.常用化学发光免疫分析技术及其特点.现代医药卫生,2011,27(14):2156-2158. Nong T L.Commonly used analysis technology and characteristics of Chemiluminescenct immunoassay. Modern Medicine & Health,2011,27(14):2156-2158.
[27] Djeneba D,Joseph B,Margolick J L,et al.Multiplex measurement of proinflammatory cytokines in human serum:comparison of the Meso Scale Discovery electrochemiluminescence assay and the Cytometric Bead Array.J Immunol Methods,2011,372(1-2):71-77.
[28] 姜国华,刘忠敏.同位素示踪法研究125I-NGF在小鼠体内的吸收、分布及排泄.现代仪器,2012,18(1):10. Jiang G H,Liu Z M.Study on absorption distribution and elimination of nerve growth factor in mice by radioactivity isotope tracing method.Modern Instruments,2012,18(1):10.
[29] Ferraiolo B L,Mohler M A,Gloff C A. Protein Pharmacokinetics and Metabolism. NewYork,Plenum Press,1992.82-88, 1-10.
[30] Armando A R,Ludger S R,Zaharenko A J,et al. Combining multidimensional liquid chromatography and MALDI-TOF-MS for the fingerprint analysis of secreted peptides from the unexplored sea anemone species Phymanthus crucifer.J Chromatogr B,2012,903(16):30.
[31] Navarrete A,Paz M,Martínez A, et al. Simultaneous online SPEHPLC-MS/MS analysis of docetaxel,temsirolimus and sirolimus in whole blood and human plasma.J Chromatogr B,2013,921(6):35.
[32] 彭晓云.LC-MS/MS测定人血清中英夫利昔单抗血药浓度方法的建立及临床应用. 广州:华南理工大学,2015. Peng X Y. Development and validation of LC-MS/MS method for the quantitation of infliximab in human serum. Guangzhou:South China University of Technology,2015.
[33] Jiang H,Xu W,Titsch C A,et al.Innovative use of LC-MS/MS for simultaneous quantitation of neutralizing antibody,residual drug,and human immunoglobulin G in immunogenicity assay development.Analytical Chemistry, 2014,86(5):2673-2680.
[34] Terai T,Nagano T.Fluorescent probes for bioimaging applications.Curr Opin Chem Biol,2008,12(5):515-521.
[35] Bentolila L A,Ebenstein Y,Weiss S.Quantum dots for in vivo smal l-animal imaging.Journal of Nuclear,2009,50(4):493-496.
[36] 覃光炯,高云华.同步荧光法测定大鼠血浆中牛血清白蛋白的研究.影像科学与光化学,2010,28(5):354-360. Qin G J,Gao Y H.Study on the determination of bovine serum albumin in rat plasma by synchronous fluorescence spectrometry.Imaging Science and Photochemistry,2010,28(5):354-360.
[37] Kameia N,Morishitaa M, Kanayamab Y.Molecular imaging analysis of intestinal insulin absorption boosted by cell-penetr-ating peptides by using positron emission tomography.J Controll Release,2010,146(1):16. |
|
Viewed |
|
|
|
Full text
|
|
|
|
|
Abstract
|
|
|
|
|
Cited |
|
|
|
|
| |
Shared |
|
|
|
|
| |
Discussed |
|
|
|
|
