Recent advances in structural mass spectrometry methods in the context of biosimilarity assessment: from sequence heterogeneities to higher order structures

Biotherapeutics and their biosimilar versions have been flourishing in the biopharmaceutical market for several years. Structural and functional characterization is needed to achieve analytical biosimilarity through the assessment of critical quality attributes as required by regulatory authorities....

Full description

Saved in:
Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2023-11, Vol.236, p.115696-115696, Article 115696
Main Authors: Castel, Jérôme, Delaux, Sarah, Hernandez-Alba, Oscar, Cianférani, Sarah
Format: Article
Language:English
Subjects:
Analytical chemistry
Biosimilar
Chemical Sciences
Higher order structure
Life Sciences
Monoclonal antibody
Pharmaceutical sciences
Structural mass spectrometry
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Biotherapeutics and their biosimilar versions have been flourishing in the biopharmaceutical market for several years. Structural and functional characterization is needed to achieve analytical biosimilarity through the assessment of critical quality attributes as required by regulatory authorities. The role of analytical strategies, particularly mass spectrometry-based methods, is pivotal to gathering valuable information for the in-depth characterization of biotherapeutics and biosimilarity assessment. Structural mass spectrometry methods (native MS, HDX-MS, top-down MS, etc.) provide information ranging from primary sequence assessment to higher order structure evaluation. This review focuses on recent developments and applications in structural mass spectrometry for biotherapeutic and biosimilar characterization. •The structural MS toolbox affords interesting methods for biosimilarity assessment.•MS approaches provides detection of small differences in biosimilar/originator mAbs.•Native MS coupled to size exclusion chromatography allows size variants evaluation.•Ion mobility spectrometry rapidly detects subtle changes in protein conformation.•HDX-MS is a key technique for higher order structure comparison of biosimilars.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2023.115696