Our human GEX® platform is the best choice when working with defucosylated antibodies, complex molecules or glycosylated proteins.
GEX® technology allows the optimization of glycosylation to improve critical quality attributes for better clinical performance, such as potency, bioavailability, stability and/or immunogenicity.
This technology is based on a human cell line family optimized for both product quality optimization and fast, highly reproducible, high yield glycoprotein manufacturing.
An established continuous biomanufacturing process provides homogenous and stable glycosylation patterns and overall consistent batch-to-batch product quality.
Different biopharmaceuticals expressed in GEX® have been approved by FDA and European authorities. Regulatory authorities (US and EU) have confirmed that the previously performed cell line characterization according to appropriate guidance is adequate for production of biopharmaceuticals for clinical studies and market entry.
The GEX® technology platform is proven for:
- Antibodies of different isotypes (e.g., IgG, IgM, IgA)
- Defucosylated antibodies
- Bispecific antibodies/fragments
- Difficult-to-express and/or complex glycosylated proteins
- Minimized batch-to batch variations proteins
- Blood factors
- Protein hormones
- Fusion proteins with extended serum half-life
Key Features of GEX®:
- Human cell lines with stable expression
- Manufacturing process with a reliable outcome, product quality, batch-to-batch consistency and high productivity
- ~15-22 g/L* IgG ( incl. low fucose)
- ~10-15 g/L* IgA
- ~3 g/L* IgM
- ~0.2 g/L* Glycoprotein Hormones (e.g. FSH)
- ~4 g/L* Blood Factors etc.
To date, more than 40 GMP production runs (up to 1000 L scale) have been performed with GEX® cell lines in a variety of projects. These have exhibited unique reproducibility, with no significant differences between batches, batch sizes, bioreactor scales or manufacturing facilities. This guarantees flexible and reliable manufacturing with highly reproducible quality.
A toolbox of diverse GEX® cell lines
Since diverse products need different glycosylation characteristics for their optimal activity, we offer a toolbox of diverse GEX® cell lines:
- mAb-Express for optimized glycosylation of antibodies, including low core-fucosylation, high galactosylation, bisGlcNAc, and sialylation. This combination allows a maximal increased ADCC (antibody-dependent cell-mediated cytotoxicity) activity.
- SialoMax for maximal sialylation, including α2,3 and α2,6 sialylation
- SialoFlex for optimization of the sialylation degree, allowing the generation of various sialylation degrees
- FucoFlex for optimization of the fucosylation degree, allowing the generation of various fucosylation degrees and thus the improvement of ADCC activity
Process platform for:
- A manufacturing process with a reliable outcome
- Consistent batch-to-batch product quality, resulting in reduced downstream costs
- Homogeneous and stable glycosylation profile
- Minimal product aggregation
- Cost-effective large-scale manufacturing