<abstract xmlns="http://www.w3.org/1999/xhtml">

Size exclusion chromatography (SEC) has become a powerful tool for analysing size variants of biologic drugs in their native form. Modern SEC can be defined by the use of chromatographic columns packed with sub-3 µm particles, allowing an increase in method throughput compared to that of conventional SEC.
We performed the forced degradation study of adalimumab, the first genetically engineered fully humanised immunoglobulin G1 monoclonal antibody, and evaluated tha possibilities of an advanced SEC column packed with sub-3 µm particles for elucidation of the degradation pathway. Our results revealed the main adalimumab degradation products to be antibody fragments. Acidic and basic conditions had the most intensive effect on the degradation of the adalimumab while the drug exhibits relative stability under thermal and photolytic stress conditions.
The AGREE and AGREEprep calculators were used for the evaluation of the environmental performance of the forced degradation procedure. The results of the green score evaluation are presented as round pictograms with a circle in the centre that shows the overall score of 0.81 and 0.61, respectively. Both pictograms are highlighted in green, indicating the eco-friendly conditions.
</abstract>

Size exclusion chromatography (SEC) has become a powerful tool for analysing size variants of biologic drugs in their native form. Modern SEC can be defined by the use of chromatographic columns packed with sub-3 µm particles, allowing an increase in method throughput compared to that of conventional SEC.
We performed the forced degradation study of adalimumab, the first genetically engineered fully humanised immunoglobulin G1 monoclonal antibody, and evaluated tha possibilities of an advanced SEC column packed with sub-3 µm particles for elucidation of the degradation pathway. Our results revealed the main adalimumab degradation products to be antibody fragments. Acidic and basic conditions had the most intensive effect on the degradation of the adalimumab while the drug exhibits relative stability under thermal and photolytic stress conditions.
The AGREE and AGREEprep calculators were used for the evaluation of the environmental performance of the forced degradation procedure. The results of the green score evaluation are presented as round pictograms with a circle in the centre that shows the overall score of 0.81 and 0.61, respectively. Both pictograms are highlighted in green, indicating the eco-friendly conditions.

Size exclusion chromatography as green support for forced degradation study of adalimumab

Faculty of Pharmacy and Biochemistry Department of Pharmaceutical Analysis

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Size exclusion chromatography (SEC) has become a powerful tool for analysing size variants of biologic drugs in their native form. Modern SEC can be defined by...

Size exclusion chromatography as green support for forced degradation study of adalimumab

Published Online: Dec 26, 2023

Page range: 709 - 721

Accepted: Nov 24, 2023

DOI: https://doi.org/10.2478/acph-2023-0044

Keywords
inflammatory bowel disease, biopharmaceuticals, adalimumab, size exclusion chromatography, forced degradation study

© 2023 Jelena Kovačić et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Size exclusion chromatography as green support for forced degradation study of adalimumab

Published Online: Dec 26, 2023

Page range: 709 - 721

Accepted: Nov 24, 2023

DOI: https://doi.org/10.2478/acph-2023-0044

Keywordsinflammatory bowel disease, biopharmaceuticals, adalimumab, size exclusion chromatography, forced degradation study

© 2023 Jelena Kovačić et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Keywords
inflammatory bowel disease, biopharmaceuticals, adalimumab, size exclusion chromatography, forced degradation study