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 & PSGs:
Impurity Considerations: Synthetic peptides must match or stay below the impurity levels of reference biologics. Any new impurity > 0.5% is deemed unacceptable.
Non-Clinical Immunogenicity Assessment: FDA recommends in silico, in vitro, and in vivo assays to evaluate peptide-related and process-related impurities.
Product-Specific Guidances (PSGs): Provide FDA’s current scientific recommendations for demonstrating pharmaceutical equivalence and bioequivalence of peptide generics.
Risk-Based Approach: Factors like peptide size, sequence homology, administration route, and clinical history determine the level of immunogenicity risk assessment required.
Why It Matters?
As the market for peptide-based therapeutics grows, robust immunogenicity evaluation is critical for regulatory approval and patient safety. Aligning with FDA guidance ensures a smoother ANDA approval process for synthetic peptide generics.
Read also:
- Impurity Specification Across Different Regulatory Bodies
- Elemental Impurities Risk Assessment for Pharmaceutical Products
Resource Person: Shubham Sonu