Assessment of drug immunogenicity (IMG) is a regulatory requirement and is considered part of the safety evaluation that all protein drugs undergo. With several years of experience within immunogenicity assessment of large molecules (Biologics and Biosimilars) we have access to a range of immunogenicity assays for detection and confirmation of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) supporting pre-clinical and clinical studies.
Our scientists are experienced in the development and validation of qualitative and semi-quantitative immunoassays.
A multi-tiered approach is used to measure ADAs and NAbs. During the first tiers, we focus on detecting anti-drug antibodies (ADAs) that bind to the biological drug. Samples are then screened for the presence of antibodies and any potentially ADA positive samples are retested for confirmation of the specificity of binding. For relevant cases, confirmed ADA positive samples will be titrated.
Through the combined use of our extensive LBA immunogenicity knowledge and core technology iLite® for our cell-based Neutralizing Antibody bioassays, we can offer a full charactarization of NAbs.
This thorough approach gives our clients a confirmed and documented approach to immunogenicity studies.