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    Bioassays for biological activity and potency determination

    products-servicesBioassay GmbH
    May 25th 2021

    Bioassay GmbH laboratories possess the expertise and facilities required to perform biopharma efficacy assays to characterize the properties of active pharmaceutical ingredients and drugs and their therapeutic efficacy against targeted indications, both in-vivo and in-vitro.

    Bioassay’s long program of potency assay development has produced a wide range of established cGMP in-vitro and in-vivo to measure biological activity, or potency, of substances. These include cell-based potency assays, FACS-Based Receptor Binding assays, specific cell line development and neutralizing antibodies.

    Bioassay’s wide range of validated potency models are particularly applicable to biopharmaceuticals like monoclonal Antibodies, Hormones or Cytokines, along with biosimilars or modified biologics, such as pegylated products.

    Potency assays

    Bioassay has developed a specific and established cGMP potency assay to test for potency in three different arenas. Examples of bioassays for potency include:

    • Antibodies: Rituximab, Trastuzumab, Adalimumab, Infliximab, Etanercept, Antibody Dependent Cellular Cytotoxicity (ADCC), Complement Dependent Cytotoxicity (CDC), and FACS-Based Binding Assays
    • Hormones: Erythropoietin, Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH), Human Chorionic Gonadotropin (HCG), and Parathyroid Hormone (PTH)
    • Growth Factors & Cytokines: Filgrastim (G-CSF), Human Growth Hormone (hGH), and Interleukins

    For further products or to meet specific customer requirements, Bioassay has a comprehensive library of existing specialized assay formats. Its analysts can also develop customized assays at short notice.

    In-vitro assays

    Analytical teams at Bioassay’s 2000 m2 laboratories at Heidelberg Technology Park use in-vitro facilities with state-of-the-art-equipment to execute and assess potency assays within quality control and development regimes for a wide range of active pharmaceutical ingredients (APIs) and drug products.

    Bioassay’s analytical teams can also develop and validate new in-vitro potency assays accordingly to ICH-Guidelines as well as in optimizing existing assay formats and transferring data into routine applications.

    In-vivo assays

    Bioassay has developed an extensive range of validated in vivo models of human disease to support preclinical drug efficacy testing. This range of efficacy assays can assist clients in choosing the correct pharmacodynamic (PD) or disease-specific model for selecting candidates, optimizing leads or validating targets.

    Bioassay’s in vivo studies are fully supported by expertise in histopathology and bioanalysis to assess and interpret how the studied therapy affects disease pathogenesis. In-vivo efficacy assays cover a series of commercially relevant fields, including nephrology models, immunotoxicology (ITOX3-Panel), and local lymph node assay (LLNA) for detection of sensitization capacity of chemicals.

    Resources

    Click on Bioassay Potency Assays  for more information.

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