References
- Liu H, Ponniah G, Zhang H, et al. In vitro and in vivo modifications of recombinant and human IgG antibodies. mAbs. 2014;6:1145–1154.
- Lui H, Nowak C, Shao M, et al. Impact of cell culture on recombinant monoclonal antibody product heterogeneity. Biotechnol Prog. 2016;32(5):1103–1112.
- Vlasak J, Lonescu R. Fragmentation of monoclonal antibodies. mAbs. 2011;3(3):253–263.
- Yu L, Vizel A, Huff MB, et al. Investigation of N-terminal glutamate cyclization of recombinant monoclonal antibody in formulation development. J Pharm Biomed Anal. 2006;42(4):455–463.
- Le Basle Y, Chennell P, Tokhadze N, et al. Physicochemical stability of monoclonal antibodies: a review. J Pharm Sci. 2019;109(1):169–190.
- Anonymous. Specifications: test procedures and acceptance criteria for biotechnological/biological products. 1999 [cited 2017 Oct 23]. Available from: https://www.ich.org/home.html
- Lapolla A, Tonani R, Fedele D, et al. Non-enzymatic glycation of IgG: an in vivo study. Horm Metab Res. 2002;34(5):260–264.
- Yuk IH, Zhang B, Yang Y, et al. Controlling glycation of recombinant antibody in fed-batch cell cultures. Biotechnol Bioeng. 2011;108(11):2600–2610.
- Quan C, Alcala E, Petkovska I, et al. A study in glycation of a therapeutic recombinant humanized monoclonal antibody: where it is, how it got there, and how it affects charge-based behavior. Anal Biochem. 2008;373(2):179–191.
- Miller AK, Hambly DM, Kerwin BA, et al. Characterization of site-specific glycation during process development of a human therapeutic monoclonal antibody. J Pharm Sci. 2011;100(7):2543–2550.
- Fischer S, Hoernschemeyer J, Mahler HC. Glycation during storage and administration of monoclonal antibody formulations. Eur J Pharm Biopharm. 2008;70(1):42–50.
- Cao M, De Mel N, Shannon A, et al. Charge variants characterization and release assay development for co-formulated antibodies as a combination therapy. MAbs. 2019 Apr;11(3):489–499.
- Kim J, Kim YJ, Cao M, et al. Analytical characterization of coformulated antibodies as combination therapy. MAbs. 2020 Jan-Dec;12(1). DOI:10.1080/19420862.2020.1738691.
- Harris C, Xu W, Grassi L, et al. 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. 2019 Nov-Dec;11(8):1452–1463.
- Reference for structure figure. Access date: January 2018. https://www.rcsb.org/structure/1HZH