We Know Your Protein Inside Out:
High End Quality Control & Analytics
If you are developing a protein, you need it to perform exactly as intended. To make sure your protein is on track at all times, we have all the analytical methods ready. We apply physico-chemical analyses and activity assays throughout its entire development and manufacturing. No surprises means less time and cost.
Our “CATS” department (Cells and Tissue Services) has established a large number of cell-based assays in hundreds of successful biologics and biosimilar projects. The assays help us analyze and compare various substances for their potency and mode-of-action. From the early stages of cell line development and at all the way up to manufacturing, our analytics assess
- Structure (including glycan)
- Content specificity
- Pharmaceutical quality
Assays are performed using cell lines or primary cells and can be offered as a stand-alone service, or even be transferred to other third parties.
The “CATS” excel in developing innovative cell-based assays from scratch, for example
- the innovative FSH potency assay
Our de-novo developed cell-based in-vitro assay for Follicle-stimulating hormone (FSH) is based on an ovarian cell line. It measures the release of hormone upon stimulation with FSH. (This assay is currently part of an inter-laboratory comparison test by the WHO. The aim is to replace the Steelman-Pohley-in vivo assay, which is based on comparative weighing of rat ovaries).
- Product specific
- Everything in-house
- Physico-chemical and activity features of molecule analyzed
- Transfer to 3rd parties
- From robust lab methods to fully validated assays for API GMP release testing