综述 |
|
|
|
|
双特异性抗体副产物去除策略 |
李谦,梁晓莹,李国柱,何清泉,谭黄虹,王子臣,徐广六,李进,樊梦妮,徐丹**() |
南京正大天晴制药有限公司 芳华药物研究院 生物部 南京 210046 |
|
Insight into the Purification Strategies for Removing the Byproducts of Bispecific Antibodies |
Qian LI,Xiao-ying LIANG,Guo-zhu LI,Qing-quan HE,Huang-hong TAN,Zi-chen WANG,Guang-liu XU,jing LI,Meng-ni FAN,Dan XU**() |
Nanjing China Tai Tianqing Pharmaceutical Co., Ltd, Fanghua Pharmaceutical Research Institute, Department of Biology, Nanjing 210046, China |
引用本文:
李谦,梁晓莹,李国柱,何清泉,谭黄虹,王子臣,徐广六,李进,樊梦妮,徐丹. 双特异性抗体副产物去除策略[J]. 中国生物工程杂志, 2022, 42(10): 60-69.
Qian LI,Xiao-ying LIANG,Guo-zhu LI,Qing-quan HE,Huang-hong TAN,Zi-chen WANG,Guang-liu XU,jing LI,Meng-ni FAN,Dan XU. Insight into the Purification Strategies for Removing the Byproducts of Bispecific Antibodies. China Biotechnology, 2022, 42(10): 60-69.
链接本文:
https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.2206043
或
https://manu60.magtech.com.cn/biotech/CN/Y2022/V42/I10/60
|
[1] |
Lim S M, Pyo K H, Soo R A, et al. The promise of bispecific antibodies: clinical applications and challenges. Cancer Treatment Reviews, 2021, 99: 102240.
doi: 10.1016/j.ctrv.2021.102240
|
[2] |
Moek K L, de Groot D J A, de Vries E G E, et al. The antibody-drug conjugate target landscape across a broad range of tumour types. Annals of Oncology, 2017, 28(12): 3083-3091.
doi: 10.1093/annonc/mdx541
pmid: 29045509
|
[3] |
Gera N. The evolution of bispecific antibodies. Expert Opinion on Biological Therapy, 2022, 22(8): 945-949.
doi: 10.1080/14712598.2022.2040987
|
[4] |
Esfandiari A, Cassidy S, Webster R M. Bispecific antibodies in oncology. Nature Reviews Drug Discovery, 2022, 21(6): 411-412.
doi: 10.1038/d41573-022-00040-2
pmid: 35246638
|
[5] |
Linke R, Klein A, Seimetz D. Catumaxomab. mAbs, 2010, 2(2): 129-136.
doi: 10.4161/mabs.2.2.11221
pmid: 20190561
|
[6] |
Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. The New England Journal of Medicine, 2017, 376(9): 836-847.
doi: 10.1056/NEJMoa1609783
pmid: 28249141
|
[7] |
Scott L J, Kim E S. Emicizumab-kxwh: first global approval. Drugs, 2018, 78(2): 269-274.
doi: 10.1007/s40265-018-0861-2
pmid: 29357074
|
[8] |
Davda J, Declerck P, Hu-Lieskovan S, et al. Immunogenicity of immunomodulatory, antibody-based, oncology therapeutics. Journal for Immunotherapy of Cancer, 2019, 7(1): 105.
doi: 10.1186/s40425-019-0586-0
pmid: 30992085
|
[9] |
Zarrineh M, Mashhadi I S, Farhadpour M, et al. Mechanism of antibodies purification by protein A. Analytical Biochemistry, 2020, 609: 113909.
doi: 10.1016/j.ab.2020.113909
|
[10] |
Chen S W, Zhang W. Current trends and challenges in the downstream purification of bispecific antibodies. Antibody Therapeutics, 2021, 4(2): 73-88.
doi: 10.1093/abt/tbab007
pmid: 34056544
|
[11] |
Li Y F. A brief introduction of IgG-like bispecific antibody purification: methods for removing product-related impurities. Protein Expression and Purification, 2019, 155: 112-119.
doi: S1046-5928(18)30607-7
pmid: 30513344
|
[12] |
Li Y F. Immunoglobulin-binding protein-based affinity chromatography in bispecific antibody purification: functions beyond product capture. Protein Expression and Purification, 2021, 188: 105976.
doi: 10.1016/j.pep.2021.105976
|
[13] |
Ridgway J B B, Presta L G, Carter P. ‘Knobs-into-holes’ engineering of antibody CH3 domains for heavy chain heterodimerization. Protein Engineering, Design and Selection, 1996, 9(7): 617-621.
doi: 10.1093/protein/9.7.617
|
[14] |
Schaefer W, Regula J T, Bähner M, et al. Immunoglobulin domain crossover as a generic approach for the production of bispecific IgG antibodies. Proceedings of the National Academy of Sciences of the United States of America, 2011, 108(27): 11187-11192.
|
[15] |
Brinkmann U, Kontermann R E. The making of bispecific antibodies. mAbs, 2017, 9(2): 182-212.
doi: 10.1080/19420862.2016.1268307
pmid: 28071970
|
[16] |
Sampei Z, Igawa T, Soeda T, et al. Identification and multidimensional optimization of an asymmetric bispecific IgG antibody mimicking the function of factor VIII cofactor activity. PLoS One, 2013, 8(2): e57479.
doi: 10.1371/journal.pone.0057479
|
[17] |
Fischer N, Elson G, Magistrelli G, et al. Exploiting light chains for the scalable generation and platform purification of native human bispecific IgG. Nature Communications, 2015, 6: 6113.
doi: 10.1038/ncomms7113
pmid: 25672245
|
[18] |
Wranik B J, Christensen E L, Schaefer G, et al. LUZ-Y, a novel platform for the mammalian cell production of full-length IgG-bispecific antibodies. Journal of Biological Chemistry, 2012, 287(52): 43331-43339.
doi: 10.1074/jbc.M112.397869
pmid: 23118228
|
[20] |
Li Y F. IgG-like bispecific antibody platforms with built-in purification-facilitating elements. Protein Expression and Purification, 2021, 188: 105955.
doi: 10.1016/j.pep.2021.105955
|
|
Wang C L, Vemulapalli B, Cao M Y, et al. A systematic approach for analysis and characterization of mispairing in bispecific antibodies with asymmetric architecture. mAbs, 2018, 10(8): 1226-1235.
doi: 10.1080/19420862.2018.1511198
pmid: 30153083
|
[21] |
Shiraiwa H, Narita A, Kamata-Sakurai M, et al. Engineering a bispecific antibody with a common light chain: identification and optimization of an anti-CD3 Epsilon and anti-GPC3 bispecific antibody, ERY974. Methods, 2019, 154: 10-20.
doi: S1046-2023(18)30096-3
pmid: 30326272
|
[22] |
de Nardis C, Hendriks L J A, Poirier E, et al. A new approach for generating bispecific antibodies based on a common light chain format and the stable architecture of human immunoglobulin G1. Journal of Biological Chemistry, 2017, 292(35): 14706-14717.
doi: 10.1074/jbc.M117.793497
pmid: 28655766
|
[23] |
Moretti P, Skegro D, Ollier R, et al. BEAT® the bispecific challenge: a novel and efficient platform for the expression of bispecific IgGs. BMC Proceedings, 2013, 7(S6): 9.
|
[24] |
Skegro D, Stutz C, Ollier R, et al. Immunoglobulin domain interface exchange as a platform technology for the generation of Fc heterodimers and bispecific antibodies. Journal of Biological Chemistry, 2017, 292(23): 9745-9759.
doi: 10.1074/jbc.M117.782433
pmid: 28450393
|
[25] |
Dietrich S, Gross A W, Becker S, et al. Constant domain-exchanged Fab enables specific light chain pairing in heterodimeric bispecific SEED-antibodies. Biochimica et Biophysica Acta (BBA) - Proteins and Proteomics, 2020, 1868(1): 140250.
doi: 10.1016/j.bbapap.2019.07.003
|
[26] |
Jang S, Song J, Kim N, et al. Development of an antibody-like T-cell engager based on VH-VL heterodimer formation and its application in cancer therapy. Biomaterials, 2021, 271: 120760.
doi: 10.1016/j.biomaterials.2021.120760
|
[27] |
Steven M. Chamow P P, Pratap L A. Capture of CH1-containing bispecific antibodies. BioProcess International, 2020, 18(5):130-144.
|
[28] |
Tustian A D, Endicott C, Adams B, et al. Development of purification processes for fully human bispecific antibodies based upon modification of protein A binding avidity. mAbs, 2016, 8(4): 828-838.
doi: 10.1080/19420862.2016.1160192
pmid: 26963837
|
[29] |
Qin T T, Wang Y, Li Y F. Separating antibody species containing one and two kappa light chain constant region by KappaSelect affinity chromatography. Protein Expression and Purification, 2020, 171: 105618.
doi: 10.1016/j.pep.2020.105618
|
[30] |
Chen X J, Wang Y, Wang Y, et al. Protein L chromatography: a useful tool for monitoring/separating homodimers during the purification of IgG-like asymmetric bispecific antibodies. Protein Expression and Purification, 2020, 175: 105711.
doi: 10.1016/j.pep.2020.105711
|
[31] |
Sharkey B, Pudi S, Wallace Moyer I, et al. Purification of common light chain IgG-like bispecific antibodies using highly linear pH gradients. mAbs, 2017, 9(2): 257-268.
doi: 10.1080/19420862.2016.1267090
pmid: 27937066
|
[32] |
Zhang L, Parasnavis S, Li Z J, et al. Mechanistic modeling based process development for monoclonal antibody monomer-aggregate separations in multimodal cation exchange chromatography. Journal of Chromatography A, 2019, 1602: 317-325.
doi: S0021-9673(19)30580-1
pmid: 31248584
|
[33] |
Tang J Q, Zhang X D, Chen T, et al. Removal of half antibody, hole-hole homodimer and aggregates during bispecific antibody purification using MMC ImpRes mixed-mode chromatography. Protein Expression and Purification, 2020, 167: 105529.
doi: 10.1016/j.pep.2019.105529
|
[34] |
Zhang Y, Cai L L, Wang Y, et al. Processing of high-salt-containing protein A eluate using mixed-mode chromatography in purifying an aggregation-prone antibody. Protein Expression and Purification, 2019, 164: 105458.
doi: 10.1016/j.pep.2019.105458
|
[35] |
Nicolas F, Franois D J, Keith W, et al. methods of purifying bispecific antibodies:EPO,EP3268390A1.2018-01-17[2018-01-17]. https://wenku.baidu.com/view/47f290b8de3383c4bb4cf7ec4afe04a1b071b0f6?fr=xueshu.
|
[36] |
Qian G. Purification of monoclonal antibodies:USA,WO2011005818A1.2011-01-13[2011-01-13]. https://wenku.baidu.com/view/06a03656f142336c1eb91a37f111f18583d00cfc.html?fr=income2-wk_app_search_ctrX-search.
|
[37] |
Chen X J, Wang Y, Li Y F. Removing half antibody byproduct by protein A chromatography during the purification of a bispecific antibody. Protein Expression and Purification, 2020, 172: 105635.
doi: 10.1016/j.pep.2020.105635
|
[38] |
Wang Y, Chen X J, Wang Y, et al. Removing a difficult-to-separate byproduct by Capto L affinity chromatography during the purification of a WuXiBody-based bispecific antibody. Protein Expression and Purification, 2020, 175: 105713.
doi: 10.1016/j.pep.2020.105713
|
[39] |
Kluters S, Hafner M, von Hirschheydt T, et al. Solvent modulated linear pH gradient elution for the purification of conventional and bispecific antibodies: Modeling and application. Journal of Chromatography A, 2015, 1418: 119-129.
doi: S0021-9673(15)01359-X
pmid: 26431858
|
[40] |
Wan Y, Zhang T, Wang Y M, et al. Removing light chain-missing byproducts and aggregates by Capto MMC ImpRes mixed-mode chromatography during the purification of two WuXiBody-based bispecific antibodies. Protein Expression and Purification, 2020, 175: 105712.
|
[41] |
Wan Y, Wang Y M, Zhang T, et al. Application of pH-salt dual gradient elution in purifying a WuXiBody-based bispecific antibody by MMC ImpRes mixed-mode chromatography. Protein Expression and Purification, 2021, 181: 105822.
doi: 10.1016/j.pep.2021.105822
|
[42] |
Gagnon P. Improved antibody aggregate removal by hydroxyapatite chromatography in the presence of polyethylene glycol. Journal of Immunological Methods, 2008, 336(2): 222-228.
doi: 10.1016/j.jim.2008.05.002
pmid: 18571666
|
[43] |
Wang Y, Chen X J, Wang Y, et al. Impact of salt concentration in mobile phase on antibody retention in Protein A, Protein L and KappaSelect affinity chromatography. Protein Expression and Purification, 2021, 178: 105786.
doi: 10.1016/j.pep.2020.105786
|
[44] |
Chen S W, Tan D, Yang Y S, et al. Investigation of the effect of salt additives in protein L affinity chromatography for the purification of tandem single-chain variable fragment bispecific antibodies. mAbs, 2020, 12(1): 1718440.
|
[45] |
Hall T, Kelly G M, Emery W R. Use of mobile phase additives for the elution of bispecific and monoclonal antibodies from phenyl based hydrophobic interaction chromatography resins. Journal of Chromatography B, 2018, 1096: 20-30.
doi: S1570-0232(18)30943-7
pmid: 30130673
|
[46] |
Wollacott R B, Casaz P L, Morin T J, et al. Analytical characterization of a monoclonal antibody therapeutic reveals a three-light chain species that is efficiently removed using hydrophobic interaction chromatography. mAbs, 2013, 5(6): 925-935.
doi: 10.4161/mabs.26192
pmid: 23995619
|
[47] |
Hall T, Wilson J J, Brownlee T J, et al. Alkaline cation-exchange chromatography for the reduction of aggregate and a mis-formed disulfide variant in a bispecific antibody purification process. Journal of Chromatography B, 2015, 975: 1-8.
doi: 10.1016/j.jchromb.2014.11.002
pmid: 25462105
|
[48] |
Ishihara T, Miyahara M, Yamamoto K. Monoclonal antibody purification using activated carbon as a replacement for protein A affinity chromatography. Journal of Chromatography B, 2018, 1102-1103: 1-7.
|
|
Viewed |
|
|
|
Full text
|
|
|
|
|
Abstract
|
|
|
|
|
Cited |
|
|
|
|
|
Shared |
|
|
|
|
|
Discussed |
|
|
|
|