We help you meet certification guidelines for market release and make informed decisions about compound ranking in your pipeline

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).

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Areas of expertise

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).

In vivo testing

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

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

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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.