Glycomonitoring to monitor faster and better biotherapeutics.
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.
Changing protein scaffold impact glycan structure
Glycosylation is a challenging quality attribute to meet regulatory compliance.
New generations of antibodies with non natural scaffold are being developed and may be difficult to express proteins.
IgG type scaffold largely impact glycoprofiles:
- Wild-type IgG1: purple
- Mutated IgG1: pink
- Fc-fusion protein: red
- Blank: blue
Glycoprofiles reflect the action of the cellular machinery on the product:
antibodies are known to display high content in fucose and variable content in galactose, thereby altering antibody cytotoxicity.
Viral capsids can display glycans
Viral vectors used for gene therapies are produced in cell lines that may widely vary upon process intensification:
There is a current need for advanced methods to assess process quality throughout the production, especially upscaling.
Glycoprofiling helps identify alteration of the capsid intactness during batch production
Glycoprofiles are reproducible among donors
Cell therapies become increasingly developed and assessing quality of cell preparations is challenging. Gaining in productivity with adherent cells requests innovative methods to control cell expansion and upscaling.
Cell surface glycans can be used as a marker of robustness during cell isolation and expansion. A reference protein can be used as a twin stanard to ensure the reproducibilty of the cultivation modes.
Assays can be also designed to define and assess cell differentiation wherever necessary.