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

• Published in: Acta Pharmaceutica Vol. 73; no. 4; pp. 709 - 721
• Main Authors: Kovačić, Jelena, Klarić, Daniela Amidžić, Turk, Nikša, Mornar, Ana
• Format: Journal Article Paper
• Language: English
• Published: Poland Sciendo 01.12.2023; De Gruyter Poland; Hrvatsko farmaceutsko društvo
• Subjects: Adalimumab; Antibodies, Monoclonal - analysis; Antibodies, Monoclonal - chemistry; biopharmaceuticals; Chromatography; Chromatography, Gel; Chromatography, High Pressure Liquid - methods; Degradation; Degradation products; Environmental performance; forced degradation study; Genetic engineering; Immunoglobulin G; inflammatory bowel disease; Monoclonal antibodies; Pictographs; Size exclusion chromatography; biopharmaceuticals; forced degradation study; size exclusion chromatography; adalimumab; inflammatory bowel disease
• ISSN: 1846-9558; 1330-0075; 1846-9558
• DOI: 10.2478/acph-2023-0044

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.