Development and validation of a novel reporter gene assay for determination of recombinant human thrombopoietin

International Immunopharmacology - Tập 99 - Trang 107982 - 2021
Jie Yuan1, Jia Li, Lihua Yang1, Yunying Lv1, Chao Wang, Zheng Jin, Xianpu Ni1, Huanzhang Xia1
1School of Life Science and Biopharmaceuticals, Shenyang Pharmaceutical University, No. 103 Wenhua Road, Shenyang, Liaoning 110016, China

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Tài liệu tham khảo

Hitchcock, 2014, Thrombopoietin from beginning to end, Br. J. Haematol., 165, 259, 10.1111/bjh.12772

Zhang, 2016, Thrombopoietin: a potential diagnostic indicator of immune thrombocytopenia in pregnancy, Oncotarget., 7, 7489, 10.18632/oncotarget.7106

Bhat, 2018, A network map of thrombopoietin signaling, J. Cell Commun. Signal., 12, 737, 10.1007/s12079-018-0480-4

Kuter, 2002, Recombinant human thrombopoietin: basic biology and evaluation of clinical studies, Blood., 100, 3457, 10.1182/blood.V100.10.3457

Kato, 1998, Native thrombopoietin: structure and function, Stem Cells., 16, 322, 10.1002/stem.160322

Xia, 2000, Thrombopoietin and the TPO receptorduring platelet storage, Transfusion., 40, 976, 10.1046/j.1537-2995.2000.40080976.x

Wolber, 2002, Thrombopoietin: The Novel Hepatic Hormone, News Physiol. Sci., 17, 6

Kuter, 2013, The biology of thrombopoietin and thrombopoietin receptor agonists, Int. J. Hematol., 98, 10, 10.1007/s12185-013-1382-0

Kuter, 1996, Thrombopoietin: biology and clinical applications, Oncologist., 1, 98, 10.1634/theoncologist.1-1-98

Ghanima, 2019, Thrombopoietin receptor agonists: ten years later, Heamatologica., 104, 1112, 10.3324/haematol.2018.212845

Ninos, 2006, The thrombopoietin receptor, c-Mpl, is a selective surface marker for human hematopoietiv stem cells, J. Transl. Med., 16, 4

Kaushansky, 2009, Molecular mechanisms of thrombopoietin signaling, J. Thromb. Haemost., 7, 235, 10.1111/j.1538-7836.2009.03419.x

Ng, 2014, Mpl expression on megakaryocytes and platelets is dispensable for thrombopoiesis but essential to prevent myeloproliferation, Proc. Natl. Acad. Sci. USA, 111, 5884, 10.1073/pnas.1404354111

Kumar, 2019, Understanding the journey of human hematopoietic stem cell development, Stem Cells Int., 2019, 2141475, 10.1155/2019/2141475

Palis, 2016, Hematopoietic stem cell-independent hematopoiesis: emergence of erythroid, megakaryocyte, and myeloid potential in the mammalian embryo, FEBS Lett., 590, 3965, 10.1002/1873-3468.12459

Zhang, 2017, Thrombopoietin receptor agonists for prevention and treatment of chemotherapy-induced thrombocytopenia in patients with solid tumours, Cochrane Database Syst. Rev., 11, CD012035

Zhou, 2019, The effect of recombinant human thrombopoietin (rhTPO) on sepsis patients with acute severe thrombocytopenia: a study protocol for a multicentre randomised controlled trial, BMC Infect Dis., 19, 780, 10.1186/s12879-019-4388-2

Penington, 1970, Isotope bioassay for “thrombopoietin”, Br. Med. J., 1, 606, 10.1136/bmj.1.5696.606

Lewis, 1974, Cyclic thrombocytopenia: a thrombopoietin deficiency, J. Clin. Pathol., 27, 242, 10.1136/jcp.27.3.242

N. Komatsu, M. Kunitama, M. Yamada, T. Hagiwara, T. Kato, H. Miyazaki, et al. Establishment and characterization of the thrombopoietin-dependent megakaryocytic cell line, UT-7/TPO. Blood. 87 (1996) 4552–4560.

M.F. Brizzi, E. Battaglia, A. Rosso, P. Strippoli, G. Montrucchio, G. Camussi, et al. Regulation of polymorphonuclear cell activation by thrompoietin. J. Clin. Invest. 99 (1997) 1576–1584.

Ohashi, 1998, Thrombopoietin stimulates proliferation and megakaryicytic differentiation of mouse pro-B cell line BF-TE22, Cytotechnology., 26, 199, 10.1023/A:1007915809529

Erickson-Miller, 2009, Preclinical activity of eltrombopag (SB-497115), an oral, nonpeptide thrombopoietin receptor r agonist, Stem Cells., 27, 424, 10.1634/stemcells.2008-0366

Page, 1996, A sensitive human cell line based bioassay for megakaryocyte growth and development factor or thrombopoetin, Cytokine., 8, 66, 10.1006/cyto.1996.0009

Zang, 2007, Expression, refolding, and characterization of recombinant thrombopoietin / stem cell factor fusion protein in Eschericha coli, Appl. Microbiol. Biotechnol., 74, 836, 10.1007/s00253-006-0734-6

Zang, 2007, A novel thrombopoietin-stem-cell factor fusion protein possesses enhanced potential in stimulating megakaryocyte proliferation and differentiation, Biotechnol. App. Biochem., 48, 135, 10.1042/BA20070063

Yang, 2014, A novel reporter gene assay for recombinant human erythropoietin (rHuEPO) pharmaceutical products, J. Pharm. Biomed. Anal., 100, 316, 10.1016/j.jpba.2014.08.003

Yao, 2019, A cell-based strategy for bioactivity determination of long-acting Fc-fusion recombinant human growth hormone, Molecules., 24, 1389, 10.3390/molecules24071389

Yao, 2019, Bioactivity determination of a therapeutic recombinant human keratinocyte growth factor by a validated cell-based bioassay, Molecules., 24, 699, 10.3390/molecules24040699

Wang, 2016, Development of a robust reporter-based assay for the bioactivity determination of anti-VEGF therapeutic antibodies, J. Pharm. Biomed. Anal., 125, 212, 10.1016/j.jpba.2016.03.042

Wang, 2017, Development of a robust reporter gene assay to measure the bioactivity of anti-PD-1/ anti-PD-L1 therapeutic antibodies, J. Pharm. Biomed. Anal., 145, 447, 10.1016/j.jpba.2017.05.011

Fu, 2018, Development of a robust reporter gene based assay for the bioactivity determination of IL-5-targeted therapeutic antibodies, J. Pharm. Biomed. Anal., 148, 280, 10.1016/j.jpba.2017.09.032

Qin, 2019, Responsive cells for rhEGF bioassay obtained through screening of a CRISPR/Cas9 library, Sci. Rep., 9, 3780, 10.1038/s41598-019-40381-4

Yu, 2018, Measuring the bioactivity of anti-IL-6/ anti-IL-6R therapeutic antibodies: presentation of a robust reporter gene assay, Anal. Bioanal. Chem., 410, 7067, 10.1007/s00216-018-1307-0

Guo, 2020, A robust and stable reporter gene bioassay for anti-IgE antibodies, Anal. Bioanal. Chem., 412, 1901, 10.1007/s00216-020-02442-w

Wang, 2020, Development of reporter gene assays to determine the bioactivity of biopharmaceuticals, Biotechnol. Adv., 39, 10.1016/j.biotechadv.2019.107466

Niu, 2020, Development of a novel reporter gene assay for platelet-derived growth factor-BB bioactivity, Biologicals., 63, 68, 10.1016/j.biologicals.2019.11.004

Yu, 2019, Development and validation of a reporter-cell- line-based bioassay for therapeutic soluble gp130-Fc, Molecules., 24, 3845, 10.3390/molecules24213845

Li, 2016, Method development and validation for pharmaceutical tablets analysis using transmission Raman spectroscopy, Int. J. Pharm., 498, 318, 10.1016/j.ijpharm.2015.11.049

Hawe, 2012, Forced degradation of therapeutic proteins, J. Pharm. Sci., 101, 895, 10.1002/jps.22812

Kuter, 2013, 1217

T. Kato, Thrombopoietin. Handbook of Hormones., Elservier Inc., Amsterdam, Netherland, 2015, pp. 319–322.

ICH. International Conference on Harmonization (ICH) Guidelines ICH Q2(R1), Validation of Analytical Procedures: Text and Methodology; ICH: Geneva, Switzerland, 2005.

Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia, 5th ed.; People’s Medical Publishing House: Beijing, China, 2020.