Liquid chromatography mass spectrometry (LC–MS) is the most commonly used technique
for the characterization of antibody variants. MAb-X and mAb-Y are two approved IgG1 …

This study shows that state-of-the-art liquid chromatography (LC) and mass spectrometry
(MS) can be used for rapid verification of identity and characterization of sequence variants …

Liquid chromatography–tandem mass spectrometry-based proteomics for peptide mapping
and sequencing was used to characterize the marketed monoclonal antibody trastuzumab …

In the biosimilar eon, where various analytical platforms are needed to show biosimilarity,
we demonstrate the use of surface plasmon resonance biosensor as a label-free interaction …

The concept of biosimilar was established in the early 2000s in EU. Currently, the regulatory
framework for biosimilar has also been established in the US, Japan, and other countries. As …

Mass spectrometry (MS) is one of the key analytical techniques to detect and to identify
primary sequence differences, to assess similarity and to evaluate batch variability of …

OBJECTIVE: Nowadays, recombinant monoclonal antibodies developed as biosimilar
domains in application category for Investigational New Drug in domestic. The quality …

During early stage development of a therapeutic IgG1 monoclonal antibody, high levels of
low molecular weight (LMW) peaks were observed by high performance size-exclusion …

The development and approval processes of biosimilar mAbs depend on their comparability
to originators. Therefore, analytical comparisons are required to assess structural features …

Biosimilar monoclonal antibodies (mAbs) are making their way onto the drug market.
Because these are complex molecules in terms of structure and function, assessing …