Evidence map›Paper›PMID 40607385›Full record

ReviewFrontiers in immunology2025

Immunogenicity of therapeutic peptide products: bridging the gaps regarding the role of product-related risk factors.

Montserrat Puig, Sophie Shubow

Abstract readReview
In one paragraph

Review in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Review
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  10. Self-Assembling Short Peptide Carriers for Gene Delivery.International journal of molecular sciences · 2026
    Review
  11. Review
  12. Peptide-based drug design using generative AI.Chemical communications (Cambridge, England) · 2026
    Review
  13. Peptide-Based Approaches for Pain Relief and Healing in Wounds.International journal of molecular sciences · 2026
    Review
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  15. Review
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  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Montserrat PuigOffice of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States.
Sophie ShubowOffice of Clinical Pharmacology, Office of Translational Sciences; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The global market for therapeutic peptides is projected to continue to grow at a fast pace in the coming years in response to high demand for these products. The increasing complexity of chemical and recombinant peptide manufacturing processes may impact product quality attributes, including as related to immunogenicity risk. While it is well established that product-related factors, including impurities, can impact the immunogenicity of a biologic product, assessing the actual impact of a specific product quality attribute on immunogenicity is difficult. Despite significant advances in the analytical characterization of complex peptide products, gaps still exist in our understanding of the significance of impurities to the overall peptide immunogenicity risk, and questions remain about what the best-suited control strategies are. These gaps have the largest impact on the assessment of immunogenicity risk of follow-on therapeutic peptide products, when clinical data are not available to inform that risk. Current regulatory guidance on impurity qualification thresholds is sparse, and

Indexed as

Biological ProductsPeptidesAnimalsDrug ContaminationHumansRisk AssessmentRisk FactorsBiological ProductsPeptidesimmunogenicityimpuritiesqualification thresholdrisk assessmenttherapeutic peptides

Identifiers

PMID40607385
PMCPMC12213570

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.