ABSTRACT
Vaccines and immunotherapies are designed to engage the human immune system in fighting disease, unwanted immunogenicity can be a major problem for protein-based therapeutics. Some patients produce antidrug antibodies (ADA), which might lead to drug inactivation or adverse effects. In rushing to deliver new drugs to market, some biotherapeutics developers have overlooked factors that contribute to protein immunogenicity. Circulating ADAs are the primary measurement used in defining an immune response to recombinant protein products. Both patient-related and product-related factors come into play, and those provide a starting point for immunogenicity risk assessment. Risk management follows from risk assessment. Biopharmaceutical companies have many options for addressing the problem of immunogenicity when it arises. Factors associated with drug administration and patient-specific conditions can be difficult for biomanufacturers to control. But risk management continues beyond market authorization, and quality could be said to include both safety and efficacy.
