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Individual Tests
All preclinical tests are also available individually. In addition, assays marked with * can also be performed on samples derived from clinical trials.
Phenotypic analysis
- differential blood counts
- histological analysis of spleen, lymph node, Peyer´s patches and thymus
- serological analysis of antibody isotype distribution using ELISA
- 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
- tumourigenicity / oncogenicity
- vaccination studies
- potency testing
Pharmacological studies in vitro
- 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)
Developement of customized assays utilizing IVC cages for test items when required