Glycosylation is a critical quality attribute of biologics. Assessment of glycosylation is key to maintain quality attributes as it impacts product lifespan, immunogenicity and efficacy. Glycosylation  is a non-template driven and highly process-specific modification that may lead to numerous combinations of heterogeneous glycans when cell cultivation modes are not robust enough. Therefore, Go /no Go decisions are to be made quite early in bioprocessing, especially to validate workflows and maximize productivity. There is a crucial need of advanced methods that assess glycan heterogeneity at all steps.

Eventhough a fully elucidated glycopattern of biologics is required by regulators, glycosylation cannot easily be traced online nor really controlled because glycan heterogeneity is highly versatile. No data are readily available online and as a result, product glycosylation is  often assessed post-production, found to be truncated and product efficacy is reduced. Expensive losses can be encountered as well. Product glycoprofiles do not need to be fully characterized throughout bioprocesses but rather, they need to be rapidly monitored to maximize efficacy and reproducibility  of cell line management and production.

To speed up a better and more efficient quality control, we have developed  a fast track glycomonitoring which can  provide the missing analytics daily, accelerate  and optimize the desired glycosylation to the highest titer at each step of biomanufacturing.