Exploring the analytical power of the QTOF MS platform to assess monoclonal antibodies quality attributes

PLoS One. 2019 Jul 10;14(7):e0219156. doi: 10.1371/journal.pone.0219156. eCollection 2019.

Abstract

The biopharmaceutical industry is growing at a fast pace, making nowadays 20% of the pharma market. Within this market, therapeutic monoclonal antibodies (mAbs) are the dominant product class. With the patent expirations, biosimilars and, perhaps more relevant, biobetters, are in fast development. Thus, a comprehensive characterization at the molecular level of antibodies heterogeneity such as glycoforms, post-translational modifications (PTMs) and sequence variations is of utmost importance. Mass spectrometry (MS)-based approaches are undoubtedly the most powerful analytical strategies to monitor and define an array of critical quality attributes on mAbs. In this work, we demonstrate the analytical power of the Q-TOF MS platform for comprehensive and detailed analysis at molecular levels of an in-house produced mAb. This methodology involves minimal sample preparation procedures and provides an extensive collection of valuable data in a short period of time.

MeSH terms

  • Antibodies, Monoclonal / analysis*
  • Antibodies, Monoclonal / chemistry*
  • Biosimilar Pharmaceuticals
  • Glycosylation
  • Humans
  • Mass Spectrometry / methods*
  • Protein Processing, Post-Translational

Substances

  • Antibodies, Monoclonal
  • Biosimilar Pharmaceuticals

Grants and funding

The author(s) received no specific funding for this work.