|
|
|
| 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 |
|
|
|
Abstract It has been over 25 years since the application of fusion protein in the biopharmaceutical industry. The purpose to improve the original properties of natural protein, thus a new physical and chemical characteristics and biological function, one of the most remarkable characteristic is improved the small molecular protein and polypeptide short half-life of defects. Based on the technology, the birth of the fusion-protein drugs(FPDs)is becoming a hot spot of current research and development of biological medicine. Based on the fusion protein drugs already on the market, compared with traditional protein polypeptide drugs, highlighting characteristics FPDs, mainly from the fusion antibody Fc and human serum albumin by prolonging the small molecule protein and peptide half-life,and FPDs long-term strategy was reviewed. The FPDs in vivo absorption, distribution, metabolism and excretion of the salient features are summarized. And then analyses the technology of FPDs in the body and points out the advantages and disadvantages of the current analysis technology and the development direction, and sheds light on the design, research and development of FPDs.
|
|
Received: 15 November 2016
Published: 25 April 2017
|
|
|
|
|
[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 |
|
|
|
|
