Glycosylation Analysis Services for Biologics & Biosimilars
Glycosylation analysis is one of the most important critical quality attributes (CQAs) in the development and manufacturing of biologics and biosimilars. Even minor changes in upstream cell culture conditions or downstream purification can significantly impact the glycan profile of your therapeutic protein and, with it, efficacy, safety and pharmacokinetics.
For monoclonal antibodies, the Fc and Fab glycosylation patterns are particularly crucial: Fc glycans influence effector functions such as ADCC and CDC, while Fab glycans can affect antigen binding and immunogenicity. Regulatory authorities like FDA and EMA therefore require a detailed, well-controlled characterization of N- and O-glycosylation as part of any biologic’s CMC package.
In biosimilar development, early comparison of the N-glycosylation profile of your product with a clinical-grade reference drug is essential for deciding on the cell line and process strategy. To avoid costly late changes, glycosylation heterogeneity of different batches and reference samples should be characterized at the very beginning of any biosimilar or life-cycle program.
At Biofidus, our scientists routinely and reliably determine O- and N-linked glycosylation profiles and help you define appropriate specifications and acceptance criteria for your product. In line with your needs, we adapt and, where required, qualify (according to ICH guidelines) our platform methods, tailoring them to your API/drug substance, its formulation matrix and your specific analytical questions – from early screening to comparability, biosimilarity and commercial control strategies.
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientisA
