Biologics are a class of drugs that are larger than traditional small molecule drugs. This may cause problems because large molecules can elicit and immune response in the patient. To determine if anti-drug antibodies are formed, researchers perform an immunogenicity assay. Drug is immobilized onto PhyTip columns and these are used to pull out anti-drug antibodies in complex biological samples. Anti-drug-antibodies are can have one of three effects. They can enhance the function of the drug, they can diminish the function of the drug, or they can have a neutral effect on the drug. No matter the outcome, it is imperative to capture, identify and characterize any anti-drug antibodies produced.
Anti-Drug Antibodies (ADAs) are typically masked in a sample because they’re in a complex with the high concentration of free drug in the sample. A breakthrough in the field uses an acid dissociation procedure to disrupt the drug-ADA complex. The sample is neutralized and the free ADAs are enriched and measured. This can happen in a coordinated fashion and the reproducibility of automation is a requirement.