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
Integrity
Structure (including glycan)
Identity
Purity
Content specificity
Pharmaceutical quality
Potency
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 sophisticated human artificial lymph node model
Our proprietary Human Artificial Lymph Node (HuALN) technology enables us to investigate drug-related effects on the human immune system in-vitro.
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).
Advantages
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
