Technical / White Paper
Assessing Pre-Existing Antibodies in Biotheraputic Development
Immunogenicity is the leading reason that biologics fail in clinical trials, and thus it has become imperative for drug development programs to include an immunogenicity risk assessment, leading to a clinical strategy. Detecting and characterizing the formation of treatment emergent anti-drug antibodies (ADAs) is critical in understanding patient safety, pharmacokinetics (PK), and pharmacodynamics (PD). An early strategy to minimize immune responses against the therapeutic may both improve clinical outcomes and reduce time to market.