Over the past 25 years, CIRION has developed 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 characterization assays can be performed such as:
-
Antibody titer
- Antibody isotyping
- Specificity to endogenous molecule
- Specificity to fusion protein
Cell-based assays are also available to evaluate biological activity:
- Pharmacodynamic assay (PD)
- Indirect detection method for NAbs
These are only a few examples of CIRION's service offering. 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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