A tailored lectin microarray for rapid glycan profiling of therapeutic monoclonal antibodies

ABSTRACT

Glycosylation plays a crucial role in determining the quality and efficacy of therapeutic antibodies. This necessitates a thorough analysis and monitoring process to ensure consistent product quality during manufacturing. In this study, we introduce a custom-designed lectin microarray featuring nine distinct lectins: rPhoSL, rOTH3, RCA120, rMan2, MAL_I, rPSL1a, PHAE, rMOA, and PHAL. These lectins have been specifically tailored to selectively bind to common N-glycan epitopes found in therapeutic IgG antibodies. By utilizing intact glycoprotein samples, our nine-lectin microarray provides a high-throughput platform for rapid glycan profiling, enabling comparative analysis of glycosylation patterns. Our results demonstrate the practical utility of this microarray in assessing glycosylation across various manufacturing batches or between biosimilar and innovator products. This capacity empowers informed decision-making in the development and production of therapeutic antibodies.

KEYWORDS:

• Bispecific antibody
• glycan profile
• glycosylation
• lectin microarray
• monoclonal antibody
• product quality
• therapeutic antibodies
• FDA approval

Acknowledgments

The authors would like to express their gratitude to Julianne Twomey, Alexis Dean, and Serge Beaucage from the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) for their valuable feedback and critical review of the manuscript.

Disclosure statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Disclaimer

This article reflects the views of the authors and should not be construed to represent FDA’s views or policies.

Supplemental material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/19420862.2024.2304268.

Additional information

Funding

This work was funded by the U.S. Food and Drug Administration.