Immunogenicity Assessments – Frequently Asked Questions

Immunogenicity is a critical factor in the development of therapeutic proteins, as it can impact both their effectiveness and safety. Regulatory bodies like the FDA and EMA require comprehensive immunogenicity risk assessments for the approval of biologics.

This article explores the intricacies of immunogenicity and its potential to impact promising therapies. We delve into the critical role of immunogenicity assessments throughout drug development, from initial design to regulatory approval. By understanding how to identify and mitigate these challenges early on, researchers can significantly improve the chances of success for these groundbreaking treatments. The article also sheds light on the valuable tools employed in immunogenicity assessments, including sophisticated computer modeling and real-world laboratory experiments.

Immunogenicity and safety assessment offerings, including cutting-edge assays such as the EpiScreen 2.0 time course assay and EpiscreenTM 2.0 DC:T cell assay, along with computational methods like iTope-AI and MHC Class II associated peptide proteomics (MAPPs), enable the identification of immunogenic sequence "hot spots" and the mapping of T cell epitopes.

Through a deeper understanding of immunogenicity, researchers can harness the full potential of advanced therapies, paving the way for a future of safer and more effective treatments for complex diseases.