Application note: Detection of anti-drug antibody (ADA) using single molecule counting (SMCTM) technology
All biological therapeutics have the potential to induce an immunemediated response ranging from benign to severe adverse effects.
These effects can encompass diminished clinical efficacy of the biotherapeutic being administered to hypersensitivity, an allergic reaction or even cytokine storms.
Consequently, regulatory agencies are looking to understand the implications of immunogenicity and are directing the industry to integrate programmes for immunogenicity risk management starting in early-phase drug development in clinical and pre-clinical. The US Food and Drug Administration (FDA) and pharmaceutical experts in the area of immunogenicity testing have recently published guidelines for the design and optimisation of immunoassays used in the detection of antibodies against biopharmaceutical drug products in patient samples in the absence of a drug and, more importantly, when a drug is present. The FDA recommends that screening and confirmatory IgG and IgM assays achieve a sensitivity of 100–500ng/mL (FDA Guidance 2016).