Research Information System
6th International Congress on Applied Biological Science, Adana, Turkey, 8 - 09 December 2021, pp.1-3
Therapeutic monoclonal antibodies (mAbs) have been
used for the targeted treatment of various diseases, such as cancer and
autoimmune disorders. In recent years, the biosimilar versions have been
developed and marketed due to the patent expiration for most of the mAbs. Biosimilars
are similar versions of the originator products in terms of quality, safety,
and efficacy profiles. To demonstrate the biosimilarity, orthogonal analytical
techniques, including liquid chromatography-mass spectrometry (LC-MS),
size-exclusion ultra-performance liquid chromatography (SE-UPLC), and capillary
electrophoresis-sodium dodecyl sulfate (CE-SDS) have been used. Glycosylation
is the most common post-translational modification (PTM) in mAbs and need to be
monitored during development/production steps. Additionally, low-molecular
weight (LMW) and high molecular weight (HMW) species are accepted as a critical
quality attributes for the therapeutic drugs and detected through SE-UPLC and
CE-SDS assays.