ImmunXperts’ immunogenicity testing allows you to de-risk your pipeline and optimize candidates for reduced adverse events and lower immunogenicity risk. Choose from a comprehensive immunogenicity assessment or just the components you need.
Our in vitro assays include flow cytometry, cytokine profiles, and ELISpot options
The key process in T-cell dependent antibody production is peptide presentation by antigen presenting cells to T cells, in combination with co-stimulatory signals and cytokine secretion. These three signals stimulate the T cells to proliferate and differentiate, helping the B cells produce antibodies toward the antigen.
Antibodies produced toward an administered drug (anti-drug antibodies or ADAs) are the main clinical immunogenicity problem. These ADAs can alter drug pharmacokinetics and pharmacodynamics, and negatively affect safety and efficacy. If the drug mimics an endogenous counterpart, the ADAs might also bind the endogenous protein, which can lead to severe adverse events. The process from antigen presentation until ADA production cannot (yet) be tested in vitro. Therefore, T cell proliferation is used as a surrogate marker to measure the immunogenic potential of a drug candidate in development. T-cell activation assays have a long tradition in vaccine testing (wanted immunogenicity) and can also be employed to assess possible unwanted immunogenicity induced by therapeutic proteins.