Size exclusion chromatography for the characterization and quality control of biologics

Singh, Surinder; Furman, Ran; Singh, Rajesh; Balakrishnan, Gurusamy; Chennamsetty, Naresh; Tao, Li; Li, Zheng Jian

doi:10.1080/10826076.2021.1979582

Cited by 4 publications

(1 citation statement)

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“…With its mild chromatographic conditions, SEC permits the analysis of biologic drugs with minimal impact on the conformational structure and local environment of a molecule. Thus, it is used in the manufacturing process to guide the cell-line selection and development of the purification process, formulation development, routine analysis of aggregation of biotherapeutic proteins, and stability studies (6). It is included in the list of the typically used tests in the European Pharmacopoeia guidance document entitled ''Technical Guide for the Elaboration of Monographs on Synthetic Peptides and Recombinant DNA Proteins" (7).…”

Section: Introductionmentioning

confidence: 99%

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

Kovačić,

Klarić,

Turk

et al. 2023

Acta Pharmaceutica

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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.

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Section: Introductionmentioning

confidence: 99%