Immunogenicity
Generation of anti-drug antibodies (ADA) against a therapeutic protein can cause allergic or anaphylactic reactions, reduction in efficacy or induction of autoimmunity. Therefore, immunogenicity testing is an mandatory regulation in pre-clinical and clinical development of therapeutic proteins and peptides.
Testing strategy
Our testing strategy is based on the most current recommendations for immunogenicity testing.
Test formats
- The Bridging ELISA format allows one test format to be used in all species, thus accompanying a pharmaceutical product through all phases of development and marketing.
- Alternatively, the classical Sandwich ELISA approach can be employed for a quick assessment of drug immunogenicity in one individual species.
- Specialized assays for the detection of neutralizing antibodies (NADA) are conceived as competitive ligand-binding assays or as in-vitro cell-based assays.
- All assays at MicroCoat are subjected to a careful characterization and validation prior to use.
For more information, please contact MicroCoat by phone, email or fax.
