What is ADA?

ADA describes the immune response triggered by the therapeutic compound or its delivery vehicle in the body. The biologics immune system marks external therapeutics as foreign invaders and initiates a subsequent reaction such as generation of antibodies to remove or production of specific enzyme to destroy, which can impact the efficacy and safety of the biological drug. Thus, it is important for immunogenicity testing to measure any adverse immune response from biologics generated by external therapeutic biomolecules, typically measuring the induce anti-drug antibodies (ADA). Comprehensive understanding of data of anti-drug antibody, including its incidence, kinetics and magnitude, as well as its neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and the related clinical impact, will strongly enhance clinical management of patients treated with biologic drugs.

Our Experience on ADA Testing

We have a strong scientist team with deep expertise with anti-drug antibody (ADA) assays (screening, confirmation and titration), from preclinical to late phase study evaluation and regulatory filing. Above 70% of the scientist in our team hold a Ph.D degree in Biology, Chemistry, or relate field, with more than 5 years’ experience in designing, optimizing, and validating ADA assays. The development of immunogenicity assay is challenge as complex matrices can create considerable interference and cause inaccuracies. Our scientists, with assistance of machine learning (AI), are able to formulate case specific (for example, drug- and disease-specific aspects) strategies to provide highly sensitive, selective and robust methods with reduced interference in immunogenicity testing.

Regulatory Guidance