Original scientific paper
https://doi.org/10.2478/acph-2023-0044
Size exclusion chromatography as green support for forced degradation study of adalimumab
JELENA KOVAČIĆ
; University of Zagreb Faculty of Pharmacy and Biochemistry Department of Pharmaceutical Analysis, 10000 Zagreb, Croatia
DANIELA AMIDŽIĆ KLARIĆ
; University of Zagreb Faculty of Pharmacy and Biochemistry Department of Pharmaceutical Analysis, 10000 Zagreb, Croatia
NIKŠA TURK
ANA MORNAR
; University of Zagreb Faculty of Pharmacy and Biochemistry Department of Pharmaceutical Analysis, 10000 Zagreb, Croatia
*
* Corresponding author.
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.
Keywords
inflammatory bowel disease; biopharmaceuticals; adalimumab; size exclusion chromatography; forced degradation study
Hrčak ID:
310115
URI
Publication date:
30.12.2023.
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