Effect of the total galactose content on complement-dependent cytotoxicity of the therapeutic anti-CD20 IgG1 antibodies under temperature stress conditions
Open accessAbstract
The degree of monoclonal antibody galactosylation is known to affect complement-dependent cytotoxicity (CDC) activity by affecting C1q binding, suggesting that galactose is associated with CDC bioactivity. However, whether this association also exists under temperature stress conditions is not known. This study highlights the impact of variations in the terminal galactose content of an anti-CD20 monoclonal antibody on CDC bioactivity under high-temperature stress conditions compared with storage conditions at 2–8 °C. Drug product samples with a total galactose content of >38% showed stable CDC bioactivity at higher temperatures (45 °C), while those with 16% galactose content showed reduced CDC activity.
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UDP-Gal provides the mechanistic link between extracellular galactose and uridine supplementation and galactosylation, a key quality attribute of monoclonal antibodies.
“It provides the mechanistic link between extracellular galactose and uridine supplementation and galactosylation, a key quality attribute of monoclonal antibodies [13,50].”
From Soft sensing of intracellular states for CHO cell bioprocessing with Ensemble Kalman Filters (2026) · cites this paper as [50]
Cites
The biological activity of human monoclonal IgG anti-D is reduced by β-galactosidase treatment
Kumpel, B. M., Wang, Y., Griffiths, H. L., Hadley, A. G., & Rook, G. A. W. (1995) · Human Antibodies · doi:10.3233/hab-1995-6301 · Cited by 68 · see citing works
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Soft sensing of intracellular states for CHO cell bioprocessing with Ensemble Kalman Filters
Yu, L., del Rio Chanona, A., & Kontoravdi, C. (2026) · Journal of Process Control · doi:10.1016/j.jprocont.2026.103875
- Authors
- Bheemareddy, B. R., Pulipeta, M., Iyer, P., & Dirisala, V. R.
- Affiliations
- R&D Division, Hetero Biopharma Limited, Mahaboob Nagar, Telangana, India;
- Vignan's Foundation for Science, Technology & Research (IN)
- Corresponding author
- Dirisala, Vijaya R.
- ORCID
- Dirisala, Vijaya R.
- Venue
- Journal of Carbohydrate Chemistry
- Publisher
- Informa UK Limited
- Published
- 2019-01-02
- Volume
- 38
- Issue
- 1
- Pages
- 1-19
- ISSN
- 0732-8303 (ISSN-L)
- 1532-2327
- OpenAlex
- W2921183353
- Cited by
- 7
- References
- 1
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2022: 4
- FWCI
- 0.65
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Licence
- cc-by
- Locations
- Journal of Carbohydrate Chemistry (publishedVersion)
- Figshare (cc-by)
- Funders
- Hetero Biopharma Limited and Vignan University
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Glycosylation and Glycoproteins Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
- Keywords
- complement-dependent cytotoxicity, temperature stress, C1q binding, therapeutic antibodies
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