The FDA published notice that they were reopening a Public Docket and requesting information and comment on "Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products". The Prior call for comments only included 5 responses, so they are looking for more. The current RFI deadline is by 3Mar25. Please read the full Federal Register Notice (linked below) for background details, but it includes 6 questions the Agency is seeking information on:
1. What is the lowest and routinely achievable level of total HCPs across your well-controlled rPeptide manufacturing process(es), and how are they calculated/established?
2. What are the challenges in reducing HCP levels?
3. What analytical methods are currently being used to detect, identify, and quantify HCPs in a rPeptide product? Do you conduct comparative assessments of HCPs, such as ELISA (enzyme-linked immunosorbent assay) vs LC/MS/MS (liquid chromatography tandem mass spectrometry), during manufacturing development? What is the sensitivity of these methods for detecting HCPs and their limits of quantification? Are you using a combination of orthogonal analytical methods (such as ELISA + LC/MS/MS) for HCP control during process development and manufacturing?
4. What is the generally achievable percent coverage [2] of the HCP spectrum for your HCP quantification assay? What considerations, (e.g., percent coverage of HCPs, other coverage characteristics, etc.), are important in choosing methods to evaluate HCPs?
5. Are there any qualitative or quantitative characteristics of HCPs associated with a higher likelihood of adverse clinical sequelae?
6. What tools (in silico, in vitro or in vivo studies) do you currently use or plan to use to compare the potential immunogenicity risk of two products with different HCP profiles? What is your approach to risk assessment of HCPs based upon such data?
#fda #Immunogenicity #HostCellProtein #RecombinantPeptideProduct
https://www.federalregister.gov/documents/2024/12/31/2024-31365/evaluating-the-immunogenicity-risk-of-host-cell-proteins-in-follow-on-recombinant-peptide-products
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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