A multi-tiered approach is used to measure Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs). The first tiers focus on detecting and confirming ADAs. In the following tiers, ADAs are characterized with one of these characterizations focusing on the neutralizing activity of the antibody response.
A neutralizing anti-drug antibody response occurs when the ADA inhibits the drug from having an effect on the target of the drug.
Through use of our core technology iLite® for our cell-based Neutralizing Antibody bioassays, we can offer a full characterization of NAbs. Please see list of available iLite cell lines. If needed, we can also work with customer-provided cell lines.Learn about custom development
Both the FDA and EMA recommend bioassays for immunogenicity assessment during drug development:
“FDA recommends that neutralization assays use a cell-based bioassay format depending on the therapeutic protein product’s mechanism of action because, frequently, cell-based bioassays more closely reflect the in vivo situation and therefore provide more relevant information than ligand-binding assays. ”
(Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins, Draft issued by FDA, April 2016.)
“For most biological products, the most appropriate neutralizing antibody assay is a bioassay which measures the neutralization of the bioactivity”
(Guidance on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, issued by EMA, 2012.)