Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Establishment of a Public Docket; Request for Information and Comments

The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCPs). For the purpose of this request, FDA is specifically interested in comments on suitable methods to detect, identify, and quantify HCPs, on achievable residual amounts of HCPs for recombinant peptide products, and on the use of in vitro, in silico immunogenicity assessment (IVISIA) of HCPs in a recombinant peptide (rPeptide) product. For the purpose of this request, a "follow-on" peptide product refers to the applications currently evaluated through the 505(b)(2) pathway. Although follow-on recombinant peptide products can rely on FDA's findings of safety and effectiveness for a listed drug that is a peptide product, differences in recombinant expression systems used during the peptide production could result in quality attribute differences, including in the HCP profile, which in turn, could contribute to differences in immunogenicity risks between a follow-on recombinant peptide product and the listed drug. The public comments collected will help FDA develop recommendations on how HCP control and characterization can support comparative immunogenicity risk assessment between a recombinant follow-on peptide and the listed product.