Author: [AUTHOR] Published on 1/10/2025 12:00:00 AM
FDA Reopening Comment Period on Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products
On December 31, 2024, the US Food and Drug Administration (FDA) reopened the comment period for the Federal Register notice (FRN), “
Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments” due to high interest from industry.
This notice establishes a public docket seeking substantive comments from interested parties on evaluating the immunogenicity risk of host cell proteins. For the purposes of this request, FDA is specifically interested in comments on suitable methods to detect, identify, and control host cell proteins in commercial lots of recombinant peptide products (including information on achievable residual amounts of host cell proteins in the drug product) as well as in vitro and in silico immunogenicity assessment (IVISIA) of host cell proteins in recombinant peptide products.
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 peptide production could result in quality attribute differences, including in the host cell protein profile, which in turn, could contribute to differences in immunogenicity risk between a follow-on peptide product and the relied upon listed drug. Public comments will help FDA develop recommendations for evaluation and mitigation of the immunogenicity risk associated with differences in host cell protein profiles between the follow-on and listed drug.
See the
Federal Register notice for additional information about this open docket, including what information to include when submitting comments. FDA welcomes your comments to the public docket (Docket No. FDA-2024-N-2980) until March 3, 2025.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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