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Exploratory Drug Development of NCEs / NBEs

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Immunology Services for Exploratory Drug Development

FOCUS Immunology provides MoA-defined testing packages, immunogenicity testing, functional testing of immune cells for mode-of-action analyses and immune-monitoring of clinical trials.

FOCUS Immunology provides:

  • MoA-Defined testing packages: providing solutions by addressing pertinent immunological aspects for your development compound, like the immune screening package, cytokine modulation package, antibody package, immunosuppression package, immunostimulation package and the biologicals (of higher risk) package
  • Immunogenicity testing: preclinical immunogenicity testing for novel biologicals and biosimilars according to EMEA-guideline No. EMEA / CHMP / BMWP / 14327 / 2006
  • Functional testing of immune cells for mode-of-action analyses: separation and functional testing of immune cell populations from patient and / or volunteer samples
  • Immune-monitoring of clinical trials: worldwide collection, quality-controlled processing and analysis of samples for the monitoring of immune system parameters in single and multi-centre clinical trials

For the analysis of cells of the specific and innate immune system FOCUS Immunology has established cellular assays including agonistic ligands for Toll-like and NOD-like receptors.

Cellular assays either use bulk culture-analysis or flow cytometry-based single cell analysis. Readout parameters include cell proliferation, analysis of activation markers by flow cytometry, EliSpot or ELISA, chemotaxis, NK cell activity, NO production, histamine release, oxidative burst reaction, apoptosis induction, PCR-analysis and others.

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