Glycosylation analysis studies of proteins, including assessment of glycosylation site, carbohydrate content and glycan structure in line with ICH guidelines
Glycosylation is a common post translational modification (PTM) and involves enzymatic addition of a carbohydrate (or glycan) to certain sites within a protein. Influenced by the cell line, as well as other environmental factors, changes in the N-glycosylation and O-glycosylation can potentially affect the bioactivity, safety and efficacy of the protein therapeutic.
Glycosylation is a non-heterogeneous process and as such can give rise to a wide range of different functional structures. The diversity of these protein glycoforms, as well as understanding the structure of glycans must be well understood in order to reduce risks associated with patient safety and loss of biological activity of the glycoprotein therapeutic.
Our protein characterisation scientists provide detailed glycosylation studies in accordance with relevant EMA, FDA and ICH guidelines. Our analytical programs are designed to support our clients throughout early stage development to product characterization and regulatory submission. Due to the complex nature of glycosylation structural characterisation, we deploy different approaches with each technique focused on accessing data on different aspects of the glycan or glycoprotein structure. The design of an analytical package is devised based on our expertise and experience.
Glycosylation analytical strategies are protein product specific, but typically, include determination of levels of neutral and amino monosaccharides as well as sialic acids, assessment of glycoform distribution and glycan structure elucidation. Multiple technologies are applied in these determinations including selective enzymatic cleavage, MALDI-TOF mass spectrometry and a range of chromatographic methods (HPLC, HILIC, IEX or CE-LIF).
We design programs to deliver the glycosylation information you need to meet the requirements of your development stage. Our extensive characterization programs can be provided to Good Laboratory Practice or Good Manufacturing Practice standard, as appropriate, supporting you every step of the development, regulatory submission, and ongoing manufacturing. Bringing quality and safety to life, Intertek offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
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