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Innovative Bioassays

Innovative Cell-Based Assays (CBA)

At ProBioGen we offer a broad range of cell-based assays. These sophisticated in vitro assays are pivotal for the determination of product potency and for mode-of-action analyses in biopharmaceutical drug development and release testing. We establish new assays, optimize existing cell-based assays, screen your product candidates and validate these methods for batch-release.

Product potency, functionality and mode-of-action analysis for:

Antibodies

  • Antibody-dependent cellular cytotoxicity assays (ADCC)
  • Complement-dependent cytotoxicity assays (CDC)
  • Cytotoxicity testing
  • Cellular binding assays (flow cytometric)
  • Antibody-dependent cellular phagocytosis assays (ADCP)
  • Fc-╬│-receptor binding and ligand binding assays (ELISA format)

Type I Interferons

  • Antiviral assays (AVA), according to the European pharmacopoeia
  • Commercial and proprietary reporter gene assays
  • Lymphocyte activation assay
  • MHC-I up-regulation assay
  • Anti-proliferation assays

Follicle Stimulating Hormone (FSH)

  • Cell-based assay for FSH testing (replacement of the Steelman-Pohley rat ovary test)
  • Use of a human steroidogenic ovarian tumor cell line expressing the human FSH-Receptor on its surface
  • FSH binding induces progesterone expression and secretion
  • Progesterone quantification in culture supernatant by diagnostic grade ELISA
  • Displays excellent precision and accuracy
  • Wider working range than the Steelman-Pohley in vivo assay
  • Designed for dose-response analysis using 5 decades of product concentrations
  • Validated for a biosmilar FSH product
  • Used by the NIBSC for characterization of the new WHO standard for recombinant FSH

Other Proteins

  • Cell proliferation/anti-proliferation assays (e. g. growth factors)

Immune Functional Testing

Cellular Analytics, Cell Preparation & Characterization

  • Flow cytometry (CD markers, cell cycle, apoptosis)
  • Human primary cells (preparation, separation, characterization)
  • Cell line banking, characterization and kinetics according to 'Good Cell Culture Practice' (GCCP)
  • Microscopic imaging, immuno-fluorescence services
  • Cytotoxicity testing of medical devices according to ISO 10993-5