Anti-Drug Antibody (ADA) Assays
For ADA analysis, we offer comprehensive immunogenicity testing - from generic and lean preclinical ADA formats to fully validated clinical-tiered assays, providing precise, actionable insights into unwanted immune responses.
What are ADA assays and why they matter?
ADA assays are critical tools for evaluating immunogenicity, the immune system’s response to a therapeutic drug. They detect antibodies formed against a drug, helping researchers understand potential unwanted immune responses that could compromise safety or efficacy. Assessing whether these antibodies neutralize drug function is done through NAb assays.
ADA assay types
Clinical vs. Preclinical ADA Assays
Clinical ADA assays use drug-specific reagents and a three-tiered approach: screening, confirmation, and titration.
Preclinical or nonclinical ADA assays are more flexible and guided by ICH S6, for example when:
- Altered pharmacodynamics are observed
- Unexpected shifts in drug exposure occur
- Immune-mediated reactions (e.g., anaphylaxis or vasculitis) arise
Generic and Lean ADA Assays
Generic ADA assays in preclinical species (e.g., mice or non-human primates) use commercially available reagents for reliable, cost-effective testing, saving time and resources.
Lean ADA assays streamline preclinical testing by using only two tiers (screening + confirmation or screening + titer) and can utilize commercially available polyclonal antibodies when positive controls are unavailable. Despite simplification, these assays remain scientifically robust
Additional resources
Blogs
What Are ADA Assays and Why Do They Matter? In both preclinical and clinical studies, evaluating immunogenicity, the immune system’s response to a foreign substance, is a critical factor. Anti-drug antibody (ADA) assays play a pivotal role in this evaluation, helping researchers and pharmaceutical companies determine how the immune system…
Blogs
Why Immunogenicity in Drug Development Matters Immunogenicity, why do we keep talking about it? Immunogenicity can, in the simplest of terms, be described as a subject’s ability to generate antibodies specific to the dosed protein therapeutic. Immunogenicity can be either a wanted or unwanted reaction. Wanted immunogenicity is the desired…
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