Eurofins BioPharma Product Testing offers extensive experience in all aspects of bioassay development, validation, method transfer and assay life cycle management. Our scientists of the bioassay team of Eurofins BioPharma Product Testing work closely together with you to design and execute customized cell-based bioassays and binding assays to support commercial release and stability testing. In addition, we are familiar with relative potency evaluation using different software packages.
Our excellent expertise and proven track record for GMP potency assay testing ensures successful and timely completion of your testing program.
Bioassays are one of the most challenging assays to perform due to their complex nature and as they involve quite often living organism/cells combined with extensive and handiness workflows. Consequently, assay performance requires highly skilled analysts with a well-developed method.
Exemplary overview of potency assays for biopharmaceuticals products:
Substance Class |
Type of Assay |
Assay Readouts |
Monoclonal Antibodies |
Cell Proliferation, Cell Survival, Cell Apoptosis, Reporter Gene Assay, Binding Assay, ADCC, CDC, ADCP |
Absorbance, Luminescence, Fluorescence, FACS, ELISA, SPR, BLI, Electrochemiluminiscence |
Bispecific Antibodies |
Cell Proliferation, Reporter Gene Assay, ADCC |
Luminescence, TRF |
Antibody Drug Conjugates |
Cell Survival, Cell Toxicity, Binding Assay |
Luminescence, ELISA |
mRNA |
Transfection Assay, ADCC |
Luminescence, ELISA, ADCC, SPR |
RNA Aptamer |
Cell Migration |
Fluorescence |
Hormones/Cytokines |
Cell Proliferation, Viral CPE Assay |
Absorbance, Luminescence, FACS |
Peptides |
Reporter Gene Assay |
Luminescence |
Soluble Receptors |
Cellular Binding Assay, Binding Assay |
FACS, ELISA |
Several potency assays may be required to sufficiently demonstrate the biological activity for products which have multiple MoAs.
We are committed to continuous improvement in all aspects of our operations. This includes techniques such as (semi-)automated pipetting, Kanban and 6S to enhance efficiency and the improve consistency.
At Eurofins BioPharma Product Testing we have extensive knowledge in Surface Plasmon Resonance (SPR) and Bio-Layer Interferometry (BLI) to measure biomolecular interactions such as product binding to its target or receptors such as CD16, CD32 or CD64. These techniques are particularly useful for product characterization.