Advanced assessment of the physicochemical characteristics of Remicade® and Inflectra® by sensitive LC/MS techniques.

ABSTRACT: In this study, we demonstrate the utility of ultra-performance liquid chromatography coupled to mass spectrometry (MS) and ion-mobility spectrometry (IMS) to characterize and compare reference and biosimilar monoclonal antibodies (mAbs) at an advanced level. Specifically, we focus on infliximab and compared the glycan profiles, higher order structures, and their host cell proteins (HCPs) of the reference and biosimilar products, which have the brand names Remicade® and Inflectra®, respectively. Overall, the biosimilar attributes mirrored those of the reference product to a very high degree. The glycan profiling analysis demonstrated a high degree of similarity, especially among the higher abundance glycans. Some differences were observed for the lower abundance glycans. Glycans terminated

SUBMITTER: Fang J 

PROVIDER: S-EPMC4968138 | biostudies-literature | 2016 Aug-Sep

REPOSITORIES: biostudies-literature