Mitigate Risk with Early Immunology Data
Don’t forget immunology endpoints to develop the best translational path for your therapeutic, provide detailed regulatory expectations, and offer technical expertise in required assay formats. By using this comprehensive approach, you’ll have the most rapid and cost-effective program possible, from proof-of-concept through safety assessment and the clinic.
Why Include Immunology Endpoints in Your IND Package?
The percentage of clinical candidates that fail due to safety or efficacy concerns
The average cost of drug development from discovery to market.
Failing earlier in the process greatly reduces cycle times and costs.
By the numbers – Immunology support at Charles River
- Over 90,000 samples analyzed by flow cytometry annually
- Over 140,000 cytokine and inflammatory biomarker samples analyzed annually
- And more.
The Right Immunology Endpoints for Your Drug
Large molecules, and some small molecules, can react with the immune system. Use the chart below (click to enlarge) to determine which immune endpoints, such as immunophenotyping, receptor occupancy, cytokine analysis, and immunogenicity assessment, are most appropriate for your therapy.
Immunotoxicity Testing from Safety Assessment to the Clinical Stage
We offer immunology testing support beyond IND/CTA enabling studies. Our preclinical and clinical support cover the full range of modalities from small molecules, through recombinant proteins, and to cell and gene therapies. We can support the development and validation of clinical immunological assays compliant with current regulatory expectations, flow cytometry sample analysis on a global scale, and support biomarker strategies.
If you have a program with challenging immunotoxicity considerations, we’ll work with you to develop the required analytical methods to conduct safety testing.