CIRION has developed over the past 20 years, extensive experience in the field of immunogenicity testing for biologics and biosimilars. This testing is performed to support both pre-clinical and clinical development programs. Regulatory documents have been published outlining key parameters that require appropriate evaluations for assay development and validation.
Immunogenicity testing at CIRION is performed using a multi-tiered approach:
Further chatacterization assays can be performed such as:
-
Antibody titer
- Antibody isotyping
- Specificity to endogenous molecule
- Specificity to fusion protein
Cell-based assay are also available to evaluate biological activity:
- Pharmacodynamic assay (PD)
- Undirect detection method fo NAb
These are only a few examples of what we can do. For more information, or a special request, please contact us toll free at
1-866-688-2474 or by e-mail at
businessdevelopment@cirion.com.
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