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| Strategy of Structural Analysis for Biosimilar Monoclonal Antibody Drug |
| JIA Wei, CHEN Xi, ZHOU Chun-xi, SONG Lan-kun |
| Waters Technologies Shanghai Limited, Shanghai 100026, China |
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Abstract The patent protection period of many monoclonal antibody drugs will expire, which market value will be over a hundred billion dollars. It is very important for developing countries to improve their medical system and upgrade industries. But, there are huge difficulties in developing biosimilar monoclonal antibody, which must use LCMS system to overcome. How to use LCMS system to get required data item for biosimilar monoclonal antibody was shown. Besides techniques, the work efficiency and law requirements for biosimilar drug production were also discussed.
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Received: 29 June 2012
Published: 25 October 2012
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[1] Hongwei Xie, Asish Chakraborty, Joomi Ahn, et al. Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies. mAbs, 2010,2(4): 1-16.
[2] Martin Gilar, Ying-Qing Yu, Joomi Ahn, et al. Characterization of glycoprotein digests with hydrophilic interaction chromatography and mass spectrometry. Analytical Biochemistry. 2011, 417: 80-88.
[3] Kallol Gupta, Mukesh Kumar, Padmanabhan Balaram. Disulfide bond assignments by mass spectrometry of native natural peptides: cysteine pairing in disulfide bonded conotoxins. Anal Chem, 2010, 82:8313-8319.
[4] Hongwei Xie, Weibin Chen. Fast and automatic mapping of disulfide bonds in a monoclonal antibody using SYNAPT G2 HDMS and BiopharmaLynx 1.3. Waters Application Note, 2011, 720003939EN.
[5] Kevin Blackburn, Flaubert Mbeunkui, Srijeet K Mitra. Improving protein and proteome coverage through data-independent multiplexed peptide fragmentation. Journal of Proteome Research, 2010, 9:3621-3637.
[6] Hongwei Xie, Martin Gilar, Asish Chakraborty. Monitoring deamidation progression in an antibody tryptic digest using UPLC/MSE with BiopharmaLynx and a Xevo QTof MS System. Waters Application Note. 2009, 720003168EN.
[7] John R Engen. Analysis of protein conformation and dynamics by hydrogen/deuterium exchange MS. Anal Chem, 2009, 81:7870-7875.
[8] Huang L, Gough P C, Defelippis M R. Characterization of poly(ethylene glycol) and PEGylated products by LC/MS with postcolumn addition of amines. Anal Chem, 2009, 81:567-577.
[9] Lu X, Gough P C, DeFelippis M R, et al. Elucidation of PEGylation site with a combined approach of in-source fragmentation and CID MS/MS. J Am Soc Mass Spectrom, 2010, 21:810-818.
[10] Doneanu C E, Xenopoulos A, Fadgen K, et al. Analysis of host-cell proteins in biotherapeutic proteins by comprehensive online two-dimensional liquid chromatography/mass spectrometry. mAbs, 2012,4(1): 24-44.
[11] ACQUITY UPLC H-Class Bio System. Waters Application Note, 2011, 720003482EN. |
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