Characterization of recombinant monoclonal IgG2 antibodies using LC-MS and limited 英文文献原版.docx

Accepted Manuscript Characterization of recombinant monoclonal IgG2 antibodies using LC-MS and limited Lys-C digestion Christine Nowak, Rekha Patel, Hongcheng Liu PII: S1570-0232(18)30547-6 DOI: doi:10.1016/j.jchromb.2018.05.010 Reference: CHROMB 21174 To appear in: Received date: 3 April 2018 Revised date: 8 May 2018 Accepted date: 10 May 2018 Please cite this article as: Christine Nowak, Rekha Patel, Hongcheng Liu , Characterization of recombinant monoclonal IgG2 antibodies using LC-MS and limited Lys-C digestion. The address for the corresponding author was captured as affiliation for all authors. Please check if appropriate. Chromb(2017), doi:10.1016/ j.jchromb.2018.05.010 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.  ACCEPTED MANUSCRIPT Characterization of recombinant monoclonal IgG2 antibodies using LC-MS and limited Lys-C digestion Christine Nowak, Rekha Patel and Hongcheng Liu* Product characterization, Alexion Pharmaceuticals, 100 College Street, New Haven, CT06510 * Corresponding author Email: LiuH@ Telephone: 203-271-8354 ACCEPTED MANUSCRIPT ACCEPTED MANUSCRIPT ACCEPTED MANUSCRIPT Abstract Recombinant monoclonal antibodies have been routinely characterized at intact, subunit and peptide levels by LC-MS. Papain and pepsin have been the enzymes commonly used to cleave IgG into various fragments to facilitate in-depth characterization. However, non- specific cleavage for both papain and pepsin and the need of a reducing reagent for papain has limited their usage. In contrast, IdeS has gained popular