Immunogenicity Risk Assessment: Strategies for Synthetic Peptides and Biologics
Capabilities
30 June 2026
8 am PT / 11 am ET / 4 pm BST
About our DMPK Webinar on Synthetic Peptides and Biologics
Immunogenicity remains a critical and often unpredictable risk for synthetic peptides and biologics, frequently contributing to clinical failure if not addressed early.
This webinar explores how early, orthogonal immunogenicity risk assessments can strengthen decision-making, reduce uncertainty, and help mitigate downstream development risks. You’ll learn how combining complementary in vitro and in silico approaches provides a more comprehensive understanding of immune risk across modalities.
With regulatory expectations increasingly favouring risk-based, product-specific strategies, both FDA and EMA now emphasise the importance of establishing a mechanistically driven immunogenicity assessment prior to first-in-human studies. These strategies should evolve throughout development and incorporate human-relevant new approach methodologies (NAMs) wherever possible.
Key Highlights
- Introduction to predictive immunogenicity and its role in early development
- Regulatory expectations and evolving risk assessment frameworks
- The value of early, orthogonal assessment strategies to de-risk programmes
- Modality-specific immunogenicity risk factors (peptides vs biologics)
- Comparative overview of in vitro, in silico, and integrated assessment tools
- Future trends in human-relevant methodologies and risk prediction