In 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance for the industry titled "Clinical Pharmacology Considerations for Peptide Drug Products." This document outlines the FDA’s current thinking on the immunogenicity risk assessment of peptide drugs. Recently FDA also invites industry feedback and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCPs). The FDA emphasizes the importance of a thorough immunogenicity risk assessment for peptide drug products, considering factors such as the peptide’s structure, formulation, and route of administration. The goal of this presentation is to gauge the industry’s current practices and perspectives on peptide immunogenicity assessment. It aims to initiate a discussion on strategies for evaluating immunogenicity risk and developing clinical ADA testing plans for peptide therapeutics. These discussions will ultimately contribute to the creation of an appropriate immunogenicity filing package, including an Integrated Summary of Immunogenicity (ISI) and relevant labeling content.
Learning Objectives:
• Current approaches to peptide immunogenicity assessment in the industry
• Strategies for evaluating immunogenicity risk
• Development of clinical ADA testing plans
align immunogenicity strategy with results of risk assesment in the context of current HA guidelines
