EpiVax and FDA Scientists Publish New Insights on Immunogenicity Risks of Peptide-Related Impurities in Generic Teriparatide

The study systematically evaluates teriparatide and several theoretical or observed impurities using the orthogonal methods of EpiVax's PANDA approach: in silico assessment (leveraging T-cell epitope prediction and characterization tools, EpiMatrix® and JanusMatrix®), in vitro HLA binding assays, and human T-cell assays. The study systematically evaluates teriparatide and several theoretical or observed impurities using the orthogonal methods of EpiVax's PANDA approach: in silico assessment...

PROVIDENCE, R.I., 08/12/2025 (informazione.news - comunicati stampa - salute e benessere)

The study systematically evaluates teriparatide and several theoretical or observed impurities using the orthogonal methods of EpiVax's PANDA approach: in silico assessment (leveraging T-cell epitope prediction and characterization tools, EpiMatrix^® and JanusMatrix^®), in vitro HLA binding assays, and human T-cell assays.

The investigators identified multiple impurities with higher predicted immunogenic potential than the reference teriparatide sequence, using the computational tools. Experimental analyses corroborated these predictions, revealing enhanced HLA binding and T-cell responses for several impurities compared to teriparatide itself. Notably, the study revealed a potentially tolerogenic region within the teriparatide sequence that may reduce responses to the drug, but that could be disrupted by sequence changes in the impurities.

"This collaboration with FDA scientists underscores the power of combining robust computational and wet-lab methods to better understand and mitigate immunogenicity risks in generic peptide development," said Dr. Vibha Jawa (CSO, EpiVax). "Our findings offer a practical framework for developers navigating the FDA guidance on impurity assessment and highlight opportunities to strengthen peptide drug safety."

The study may help generic peptide manufacturers identify impurities of concern that would contribute to immunogenicity and thus should be controlled in the generic drug product.

FDA Funding Statement
The research described was performed by EpiVax in collaboration with CUBRC, Inc. and FDA contributors, supported by FDA contract HHSF223018186C. The contents of this release are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

Press Contact:
Sarah Moniz
Director, Business Development
SMoniz@EpiVax.com

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