Innovative Bioassays

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. We establish new assays, optimize 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
• Fc-γ-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
• Anti-proliferation assays

Follicle Stimulating Hormone (FSH)

• Cell-based assay for FSH activity (replacement of the Steelman-Pohley rat ovary test)
• Other Proteins
• Cell proliferation assays (e. g. growth factors)

Immune Functional Testing

• Based on primary human PBMCs and PBMC derived cells:
  • Dendritic cell assays (DC assays)
  • Induced human lymphocyte assay
  • HuALN to predict immunogenicity, immunotoxcicity and immunofunction
    (click here to learn more about the HuALN technology)
• Granzyme B ELISPOT
• Immunomodulation (Cellular MHC up-regulation)

Cellular Analytics, Cell Preparation & Characterization

• Flow cytometry (CD markers, cell cycle, apoptosis)
• Human primary cells (preparation, separation, characterization)
• Cell line 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