ImmunoProfiling Lab
Custom bioassays for biopharmaceuticals
On request, we can implement custom bioassays - for instance, product activity in vitro or the assessment of neutralising activity for positive samples during immunogenicity testing.
Texcell's staff are trained in the in vitro culture of a wide range of cell types (PBMCs, macrophages, cell lines, etc.).
Cell culture can also be used to assess drug activity, cell proliferation in response to various stimuli or the neutralisation capacity of detected antibodies (immunogenicity studies).
Confirmation assays for immunogenicity studies:
Assessment of neutralising antibodies via a cell-based assay during preclinical studies or clinical trial (Phases I to IV). We offer the development or technology transfer of a bioassay based on assessment of the test drug's bio-activity. The method should be validated (in terms of sensitivity, precision, specificity, etc.) to ensure reproducibility. Testing is performed on animal or human samples, according to a validated SOP.
Potency Assays:
- Evaluation of a product's activity on specific mononuclear cells (PBMC culture followed by cytometry)
- Evaluation of a product's activity on specific cell proliferation (cell culture followed by a non-radioactive proliferation assay)
- Evaluation of a product's effect on the amount of proteins (e.g. cytokines) released into the supernatant (culture followed by a specific ELISA)
- Evaluation of a product's antiviral activity using an infectivity assay (e.g. measurement of interferon or antibodies against interferon, compared with a NIBSC reference)
