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Bioassay GmbH offers the execution and assessment of potency assays within quality control of active pharmaceutical ingredients and drug products.

Further, we have extended experience in the development and validation of new assays accordingly to ICH-Guidelines as well as in the optimization of existing assay formats and transference into routine applications.

Established potency assays running under GMP at Bioassay GmbH are listed as follows:

Antibodies

  • Rituximab
  • Trastuzumab
  • Adalimumab
  • Infliximab
  • Etanercept
  • Antibody-Dependent Cellular Cytotoxicity (ADCC)
  • Complement Dependent Cytotoxicity (CDC)
  • FACS-Based Binding Assays

Hormones

  • Erythropoietin
  • Follicle Stimulating Hormone (FSH)
  • Luteinising Hormone (LH)
  • Human Chorionic Gonadotropin (HCG)
  • Parathyroid Hormone (PTH)

Growth Factors & Cytokines

  • Filgrastim (G-CSF)
  • Human Growth Hormone (hGH)
  • Interleukins

Further assay formats already exist or can be developed at short notice

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