Immunogenicity

Assessing Immunogenicity Risk of Peptides

Assessing Immunogenicity Risk of Peptides

Immunogenicity risk assessment is crucial in developing highly purified synthetic peptide drug products, especially when referencing recombinant DNA (rDNA)-origin biologics. The FDA’s Synthetic Peptide Guidance and Product-Specific Guidances (PSGs) provide a structured approach to evaluating these risks and ensuring generic peptide safety and efficacy. Key Takeaways from the Guidance & ... Read More