EBPT Ireland expands footprint into high-throughput glycoprofiling of biologics with 2-AB labelling, offering development, qualification and validation services

Ignacio Portero Cabriada, Senior Scientist, Biopharmaceutical Chemistry Method Development and Validation, Eurofins BioPharma
Product Testing, IgnacioPorteroCabriada@eurofins.ie

Glycosylation (addition of sugar moieties) is one of the most common and predominant posttranslational modifications in proteins. Glycosylation plays a critical role in the protein structure integrity, stability and is essential for the functionality of proteins. In protein based biologics drugs, glycosylation impacts receptor binding and other recognition functions, essentially influencing the efficacy of the drug. Glycosylation is considered as a Critical Quality Attribute (CQA) for its direct impact on the safety and efficacy of the drug.

With the advent of biosimilars, “fingerprint” match for CQAs is expected by various regulatory agencies for biosimilar application, and a clinical equivalence is not enough. Hence, characterisation of glycosylation (glycol-profiling) during development and manufacturing of a drug product is essential to ensure the required safety and efficacy and, in applicable cases, to establish biosimilarity.

Glyco-profiling is usually carried out by releasing the glycan moieties from the protein, labelling them with a fluorescent dye and analysing the labelled glycan moieties using a fluorescence detector. A hydrophilic interaction liquid chromatography (HILIC) is typically used for resolving the glycan moieties in the sample. The gold standard for fluorescent labelling for glycoprofiling has been the 2-AB dye. The traditional method for glycoprofiling is time consuming (2-3 days), which poses a severe challenge in high-throughput screening and characterisation of glycan. Recent advances in technology have resulted in the development of kit-based 2-AB labelling, reducing the sample preparation time from days to 2-3 hours.

EBPT Ireland now has the capability of and capacity to execute glycoprofiling using kit-based 2-AB labelling to assist clients through all the steps of their development and manufacturing process - from analytical method development to analytical method validation and from screening and confirmatory testing to routine quality control needs related to glycoprofiling. The team has established a platform development and qualification (HILIC-UPLC) approach for this technique that would significantly reduce the overall project timelines and hence cater to the fastpaced demand in the current market. For more information, visit: www.eurofins.ie/biopharma-services