BioGenes develops immunoassays for research, drug discovery and diagnostics for highly specific and cost efficient detection of analytes.

Immunoassay Services

• Development of immunoassays including
  • Host cell protein assays (HCP assays)
  • ELISAs for preclinical or clinical pharmacokinetic studies (PK studies)
• Optimization and validation of immunoassays according to ICH guidelines
• Production of immunoassays in varying scales
• Production of ready-to-use kits according to customer’s requirements
• Analytical testing for downstream process optimization and in process control
• GMP compliant feasibility assessment
• GMP compliant release tests of the drug substance

The immunoassays are designed on the basis of micro titre plates or tubes either as competitive assays for the determination of haptens or sandwich assays for the determination of proteins.