Zdrowie i gospodarka · 25/07/2024

FDA Establishes Public Docket to Evaluate Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products

The FDA is seeking public comments on methods to detect and quantify host cell proteins in recombinant peptide products, as well as the use of in vitro and in silico assessments to mitigate immunogenicity risks in follow-on peptide products.