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[DOI] [PMC free article] [PubMed] [Google Scholar] Hong SH, Tripathi BN, Chung M-S, et al

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Clinically, however, the TPT drug product (Forteo ) is minimally immunogenic, with only 2.8% of treated patients developing antidrug antibodies (ADA) after 12 months of treatment ( Figure 1 In the 2021 synthetic peptide guidance ( FDA-2017-D-5767: ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin ), the FDA recommends that generic peptide manufacturers submit information addressing the immunogenicity risk potential of peptide impurities that may be present in the final generic drug product