Services
Immunogenicity
A major concern for pharmaceutical companies
Biotechnology-derived proteins are increasingly used as therapeutic agents that may induce unwanted humoral and cellular immune response.
The consequences of such immune reactions to a therapeutic protein range from transient appearance of anti-drug antibodies, reduced efficacy of the drug, to severe life threatening conditions (allergy, anaphylactic reactions, induction of autoimmunity).
Therefore, immunogenicity of therapeutic proteins has to be addressed at the earliest possible stage of drug development.
Immunogenicity is the capacity to induce an immune response. Every protein-based molecule has an immunogenic potential.
While immunogenicity is seeked for vaccines, it is a serious issue for therapeutic proteins (such as antibodies, peptides, hormones, etc…).
Indicia offers following solutions:
Predictive immunogenicity with T-cell amplification assays
Indicia Biotechnology proposes Immuno’line™, a range of technologies and services for:
- predictive immunogenicity assessment in Human,
- evaluation of vaccine immune response.
The CEA has gained its expertise through the design of vaccinating peptides or allergens for desensitisation, and the study of biologics. Indicia Biotechnology has leveraged this 10 years experience to build robust and high performance immunogenicity testing services.
Immuno’line™ services have been developed to bring you clear insights on the immunogenicity of your proteins and help your decisions.
Immuno'line™ services
Through its exclusive partnership with the CEA (IBiTec), Indicia Biotechnology brings 10 years of experience and unique technologies to the market, with the aim of addressing the major issue of immunogenicity. These technologies are available in the Immuno'line™ services:
Benefits of Immuno'line™
For Biologics (where goal is to avoid immune response):
• Ranking of your protein candidates vs highly and low immunogenic control proteins.
• Engineering safer versions
• Comparison of formulations
• Benchmarking of biosimilars
For Vaccines (where goal is to induce immune response):
• Design of peptide vaccines
• Validation of subunit vaccines
• Development of tools for immunomonitoring
With Immuno'line™:
• Design improved versions of your biologics
• Increase the chances of success in clinical development
• Increase the value of your molecules
Anti-drug antibodies assay
- Screening assay for identification of antibody positive samples/patients,
- Confirmation assay for validate the presence of antibodies and determining antibody specificity,
- Neutralisation assay (in general functional bioassays,
- Characterization assay which assess and characterize the clinical impact of antibodies (and possibly other components of immune responses) if these are detected/induced.
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