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Functional studies

Phenotypic analysis

  • Differential blood counts
  • Histological analysis of spleen, lymph node, Peyer´s patches and thymus
  • Serological analysis of antibody isotype distribution using ELISA
  • Immunophenotyping: flow cytometric cell surface analysis of T and B lymphocytes, NK-cells und monocytes/macrophages

Functional studies in vitro

  • Measurement of NK-activity ex vivo and following in vitro stimulation
  • Antigen dependent T-cell proliferation assays
  • Serological quantification of antibody concentrations
  • Measurement of B cell activity using hemagglutination or hemolysis assays
  • Phagocytosis or migration assays

Functional studies in vivo

  • Measurement of DTH reactions
  • Autoimmunity studies
  • Tumorigenicity / oncogenicity
  • Vaccine studies
  • Potency assays / efficacy studies

Pharmacological in vitro studies

  • Pharmacokinetics of biologicals (direct / biomarkers)*
  • Anti-drug antibody assays (screening / confirmatory ADA)*

Immunohistological analytics

  • Detection of specific antigens in selected tissues
  • Fluorescence or enzyme-linked detection systems
  • Semi-quantitative analysis and analytics of IHC
  • Tissue cross-reactivity

in vivo analysis for adventitious viruses according to

  • European Pharmacopoeia 2.6.16 (Ph.Eur.)
  • ICH guideline Q5A (CPMP/ICH/295/95)
  • Points to Consider PTC (1993)

Development of customized assays utilizing IVC cages for test items when required

  • Studying infectious agents requiring bisosafety level S2 (BSL2) laboratories (IfSG)
  • Studying genetically modified agents requiring a bisosafety level S1 (BSL1) classification  (GenTG)