Biosimilarity Demonstration with Orthogonal Analytical Techniques

Atik A. E.

6th International Congress on Applied Biological Science, Adana, Turkey, 8 - 09 December 2021, pp.15-18

  • Publication Type: Conference Paper / Full Text
  • City: Adana
  • Country: Turkey
  • Page Numbers: pp.15-18
  • Acibadem Mehmet Ali Aydinlar University Affiliated: Yes

Abstract

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.