Biopharmaceutical products hold great promise in therapeutics because of their excellent targeting ability.

This advantage is tempered with the danger of inducing an unwanted immune response in patients. Various external (i.e., patient population, disease indication, dose of administration, etc.) and internal factors (i.e., glycosylation patterns, aggregation, formulation, etc.) can have a significant impact on the immunogenic response of a biopharmaceutical.

All biopharmaceutical development programs need to quickly identify and characterize antibodies that can affect the potency and safety of the drug. Appropriate interpretation of industry expectations and regulatory documents regarding immunogenicity is required to successfully plan a productive immunogenicity program. A clear strategic path to evaluate risk and manage immunogenicity issues is essential to not only be successful in the clinic but also throughout the entire life cycle of a drug.

• This webinar first describes how to differentiate the risk associated with internal attributes of the drug from the risk derived from external factors.
• The second section provides a guideline for selecting the best methods to analyze and characterize antibodies.
• The presentation finishes with recommendations on a risk-based sampling strategy and representative clinical case studies describing the importance of immunogenicity testing not only during clinical trials but also after the drug is commercialized.