Shanhua Lin1, Zoltan Szabo1, Yury Agroskin1, Terry Zhang2, Jonathan Josephs2, and Xiaodong Liu1
With the recent growth of the biopharmaceutical industry, sensitive and fast methods are required to monitor microheterogeneity and PTMs during all stages of process development to guarantee product safety and efficacy. Therapeutic mAbs, such as rituximab, trastuzumab, infliximab, and bevacizumab, are mostly produced from mammalian cells. These biological products are heterogeneous, containing multiple charge variants and glycosylation forms. Additional modifications such as oxidation can be introduced during the manufacturing process. In the current study, mAbs are broken down into several large fragments using reduction reagent and IdeS enzyme. A fast LC/MS separation method is employed for the following two applications: 1) monitoring mAb fragments containing charge variants and oxidation variants; 2) confirming complete deglycosylation.
1.Thermo Fisher Scientific, Sunnyvale
2. Thermo Fisher Scientific, San Jose
United States
