Over the years we have developed a range of customized, product specific, potency assays in accordance with US Food & Drug Administration (FDA) and the European Medical Agency (EMA) standards, as well as guidelines issued by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
End-to-end potency testing from early development to routine batch releases
Assess biological response using a wide variety of in vitro cell-based readouts customized depending on the drug mode of action
Quantify drug-target interaction via ELISA or flow cytometry
Therapeutic Antibodies A wide range of validated analytical packages, including rituximab, trastuzumab, adalimumab, infliximab, and etanercept.
ADCC and CDC: Testing solutions using a variety of target cell lines, reporter-genes and primary cell-based assays.
Growth factor and cytokines Validated methods and GMP certified execution for the assessment of the biological activity of human products. Discover our G-CSF cell potency assay.
mRNA Vaccines: Development and validation of potency assay before moving to GMP format for batch release. Discover how we can accelerate your SARS CoV2 development.
Hormones GMP certified analytical methods to validate the biological activity of your hormones. Discover our analytical packages including, hGH as well as cGMP compliant in vivo analysis for Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH) and Human Chorionic Gonadotropin (HCG).
Specialized models for the characterization of drug candidates in the field of renal disease and diabetes. Our trained scientists can perform a variety of specialized analyses using our in vivo models to evaluate the efficacy and safety of your agent.
Evaluate direct organ function
Obtain full hematology insights
Test renal tissue functionality
Investigate biomarkers level by ELISA (Kim-1, NGAL, NAG)
Quantify ligand binding activity on peripheral blood or tissue by FACS
Evaluate immune activation with multiplexed cytokine analysis
Detect and profile pro-inflammatory cells
Assess renal tissue macrophages infiltration
Contact us to learn more about our assay development and testing services and how we can help you bring safe and effective drug products and biologics to market.
Bioassay GmbH now part of Reaction Biology Corporation.