Immunogenicity Testing Services

Our team’s scientific, medical, and technical expertise supports all aspects to assess this key aspect for the approval of the protein drugs. We understand that the measurement of adverse immune reactions is complex as it depends on many drug- and disease-specific aspects. The selection of appropriate assays and an assay strategy has to be selected specifically for each project. A generic approach for the assessment of immunogenicity is not feasible. Challenges in appropriate assay selection include the evaluation of the presence of anti-drug antibodies prior to the initiation of the treatment (pre-existing antibodies) or cross-reactivity of ADA of different isotypes.

Immunogenicity data are interpreted in the context of PK and PD data, but the clinical manifestations of the patients also must be taken into account. Sometimes the loss or reduction of drug efficacy can be observed after a long period of time, measured by disease activity scores or by MRI or other clinical parameters.

Therefore, ADA should not only be measured during drug development in pre-clinical or clinical studies, but also post-approval as a routine monitoring parameter in specialized clinical laboratories.