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).
Our BioPharma Efficacy team specializes in the characterization of monoclonal antibodies, hormones, and cytokines. We also have extensive experience working with biosimilars or modified biologics, such as pegylated products. Our BioPharma Safety assays are designed to help you mitigate off-target interactions of your drug candidate and to achieve optimal specificity from your new drug.
We have expanded our service offerings to include potency testing for veterinary biologics under veterinary Good Manufacturing Practice (GMP) license according to Art. 88 of Regulation (EU) 2019/6.
A wide range of validated analytical packages, including rituximab, trastuzumab, adalimumab, infliximab, and etanercept.
Testing solutions using a variety of target cell lines, reporter-genes and primary cell-based assays.
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).
Validated methods and GMP certified execution for the assessment of the biological activity of human products. Discover our G-CSF cell potency assay.
Development and validation of potency assay before moving to GMP format for batch release. Discover how we can accelerate your SARS-CoV2 development.
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.
