Immunogenicity Risk Assessment of Synthetic Peptide Drugs & Their Impurities
Time: 11:30 am
day: Conference Day Two
Details:
- Peptide drugs serve vital therapeutic roles across medicine, with over 80 approved for human use, careful monitoring of impurities must be implemented
- FDA proposes of new pathways like the Abbreviated New Drug Application (ANDA) to hasten access to generic peptide drugs, emphasizing the need to monitor and disclose new impurities due to potential immunogenicity risks
- EpiXav is uncovering the framework for assessing the immunogenicity risk of various bioactive peptide products, crucial for ensuring the safety and advancing peptide drug development
