One topic highlighted was the complexity of glycosylation states of low molecular weight heparin and the differences observed in sialic acid incorporation with process changes. This topic is significant to biosimilar production and may pose many challenges to the bioanalytical scientist due to differences observed in calibration curve performance and quality control recovery.

Relevant to this topic is the use of transgenic plants to produce monoclonal antibodies. This poses a risk to glycosylation patterns due to the unique pathways and carbohydrates that plants produce, including 1,3-fucose and 1,2-xylose.

Glycosylation is an enzymatic process in which a carbohydrate is attached to a hydroxyl or other functional group of another molecule. It is a form of co-translational and post-translational modification. Glycosylation is important as it can be a cause of unwanted immunogenicity in both biologicals and biosimilars.

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Immunogenicity testing in biosimilars

Protein aggregation and the generation of immune responses

Bioanalytical challenges in the development of biosimilars

Reference

1.  Colletti KS. Conference Report: Bioanalysis-related topics presented at the International Conference and Exhibition on Biowaivers and Biosimilars. Bioanalysis. 2013;5(5):529-31.

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