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mAbs Volume 8, 2016 - Issue 5
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Characterization of alanine to valine sequence variants in the Fc region of nivolumab biosimilar produced in Chinese hamster ovary cells

Yantao LiInternational Joint Cancer Institute, Second Military Medical University, Shanghai, China;State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China
,
Tuo FuInternational Joint Cancer Institute, Second Military Medical University, Shanghai, China;State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China
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Tao LiuInternational Joint Cancer Institute, Second Military Medical University, Shanghai, China;State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China
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Huaizu GuoState Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China;Shanghai Zhangjiang Biotechnology Co.
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Qingcheng GuoInternational Joint Cancer Institute, Second Military Medical University, Shanghai, China;State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China
,
Jin XuState Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China;Shanghai Zhangjiang Biotechnology Co.
,
Dapeng ZhangInternational Joint Cancer Institute, Second Military Medical University, Shanghai, China;State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China
,
Weizhu QianState Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China;Shanghai Zhangjiang Biotechnology Co.
,
Jianxin DaiInternational Joint Cancer Institute, Second Military Medical University, Shanghai, China;State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China
,
Bohua LiInternational Joint Cancer Institute, Second Military Medical University, Shanghai, China;State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China
,
Yajun GuoState Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China;School of Pharmacy, Liaocheng University, Liaocheng, China;School of Bioscience and Bioengineering, South China University of Technology, Guangzhou, China
,
Sheng HouInternational Joint Cancer Institute, Second Military Medical University, Shanghai, China;State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, ChinaCorrespondence[email protected] [email protected]
&
Hao WangInternational Joint Cancer Institute, Second Military Medical University, Shanghai, China;State Key Laboratory of Antibody Medicine and Targeted Therapy, Shanghai, China;School of Pharmacy, Liaocheng University, Liaocheng, ChinaCorrespondence[email protected] [email protected]
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Pages 951-960 | Received 17 Dec 2015, Accepted 24 Mar 2016, Published online: 28 Apr 2016

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Jane E. Rogers, Kohei Yamashita, Matheus Sewastjanow-Silva, Ernesto Rosa Vicentini, Rebecca Waters & Jaffer A. Ajani. (2023) Nivolumab combination therapy as first-line treatments for unresectable, advanced or metastatic esophageal squamous cell carcinoma. Expert Review of Anticancer Therapy 23:6, pages 565-571.
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Claire Harris, Weichen Xu, Luigi Grassi, Chunlei Wang, Abigail Markle, Colin Hardman, Richard Stevens, Guillermo Miro-Quesada, Diane Hatton & Jihong Wang. (2019) Identification and characterization of an IgG sequence variant with an 11 kDa heavy chain C-terminal extension using a combination of mass spectrometry and high-throughput sequencing analysis. mAbs 11:8, pages 1452-1463.
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François Griaud, Andrej Winter, Blandine Denefeld, Manuel Lang, Héloïse Hensinger, Frank Straube, Mirko Sackewitz & Matthias Berg. (2017) Identification of multiple serine to asparagine sequence variation sites in an intended copy product of LUCENTIS® by mass spectrometry. mAbs 9:8, pages 1337-1348.
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Tao Liu, Yantao Li, Jin Xu, Qingcheng Guo, Lei Zhu, Tuo Fu, Jun Li, Dapeng Zhang, Weizhu Qian, Xinli Zhou, Huaizu Guo & Sheng Hou. (2022) Mass spectrometry-based multi-attribute method for mutation analysis in the early development of therapeutic proteins. Journal of Pharmaceutical and Biomedical Analysis 220, pages 115018.
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Anushikha Thakur, Rekha Nagpal, Avik Kumar Ghosh, Deepak Gadamshetty, Sirisha Nagapattinam, Malini Subbarao, Shreshtha Rakshit, Sneha Padiyar, Suma Sreenivas, Nagaraja Govindappa, Harish V. Pai & Ramakrishnan Melarkode Subbaraman. (2021) Identification, characterization and control of a sequence variant in monoclonal antibody drug product: a case study. Scientific Reports 11:1.
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Hong Wang, Linping Wu, Can Wang, Jin Xu, Hongrui Yin, Huaizu Guo, Luxia Zheng, Hong Shao & Gang Chen. (2021) Biosimilar or Not: Physicochemical and Biological Characterization of MabThera and Its Two Biosimilar Candidates. ACS Pharmacology & Translational Science 4:2, pages 790-801.
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Thomas Flad & Chris Chumsae. 2021. Monoclonal Antibodies. Monoclonal Antibodies 93 119 .
Ohnmar Khanal, Vijesh Kumar & Abraham M. Lenhoff. (2020) Displacement to separate host‐cell proteins and aggregates in cation‐exchange chromatography of monoclonal antibodies. Biotechnology and Bioengineering 118:1, pages 164-174.
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Young Hye Hahm, Sung Ho Hahm, Hyoun Young Jo & Yeong Hee Ahn. (2018) Comparative Glycopeptide Analysis for Protein Glycosylation by Liquid Chromatography and Tandem Mass Spectrometry: Variation in Glycosylation Patterns of Site-Directed Mutagenized Glycoprotein. International Journal of Analytical Chemistry 2018, pages 1-10.
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Trina Mouchahoir & John E. Schiel. (2018) Development of an LC-MS/MS peptide mapping protocol for the NISTmAb. Analytical and Bioanalytical Chemistry 410:8, pages 2111-2126.
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Christof Regl, Therese Wohlschlager, Johann Holzmann & Christian G. Huber. (2017) A Generic HPLC Method for Absolute Quantification of Oxidation in Monoclonal Antibodies and Fc-Fusion Proteins Using UV and MS Detection. Analytical Chemistry 89:16, pages 8391-8398.
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Jennifer Liu, Tamer Eris, Cynthia Li, Shawn Cao & Scott Kuhns. (2016) Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab. BioDrugs 30:4, pages 321-338.
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