Evidence map›Paper›PMID 27044944›Full record

ReviewJournal of pharmaceutical sciences2016

Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges.

Wim Jiskoot, Grzegorz Kijanka, Theodore W Randolph, John F Carpenter, Atanas V Koulov, Hanns-Christian Mahler, Marisa K Joubert, Vibha Jawa, Linda O Narhi

Abstract readReview
In one paragraph

Review in Journal of pharmaceutical sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing 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

37 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Beyond Efficacy: Ensuring Safety in Peptide Therapeutics through Immunogenicity Assessment.Journal of peptide science : an official publication of the European Peptide Society · 2025
    Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Discrete, Chiral Polymer-Insulin Conjugates.Journal of the American Chemical Society · 2022
    Article
  17. Article
  18. Article
  19. Immunogenicity of Endolysin PlyC.Antibiotics (Basel, Switzerland) · 2022
    Article
  20. 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

9 authors.

Wim JiskootDivision of Drug Delivery Technology, Leiden Academic Centre for Drug Research, Leiden University, P.O. Box 9502, RA Leiden 2300, The Netherlands.
Grzegorz KijankaDivision of Drug Delivery Technology, Leiden Academic Centre for Drug Research, Leiden University, P.O. Box 9502, RA Leiden 2300, The Netherlands.
Theodore W RandolphCenter for Pharmaceutical Biotechnology, Department of Chemical and Biological Engineering, University of Colorado - Boulder, Boulder, Colorado 80309.
John F CarpenterCenter for Pharmaceutical Biotechnology, Department of Pharmaceutical Sciences, University of Colorado Denver, Anschutz Medical Campus, Aurora, Colorado 80045.
Atanas V KoulovPharma Technical Development (Europe) Biologics, Basel 4070, Switzerland.
Hanns-Christian MahlerPharma Technical Development (Europe) Biologics, Basel 4070, Switzerland.
Marisa K JoubertAmgen Inc., Process Development, Thousand Oaks, California 91320.
Vibha JawaAmgen Inc., Medical Sciences, Thousand Oaks, California 91320.
Linda O NarhiAmgen Inc., Process Development, Thousand Oaks, California 91320. Electronic address: lnarhi@amgen.com.

Funding

Biotechnology Research Partnerships Renewal: Aggregation of Therapeutic ProteinsR01EB006006 · NIBIB · UNIVERSITY OF COLORADO · PI RANDOLPH, THEODORE W · 2006 to 2017
$7.2M
NIBIB NIH HHS R01 EB006006
6 · The paper itself

Abstract

The success of clinical and commercial therapeutic proteins is rapidly increasing, but their potential immunogenicity is an ongoing concern. Most of the studies that have been conducted over the past few years to examine the importance of various product-related attributes (in particular several types of aggregates and particles) and treatment regimen (such as dose, dosing schedule, and route of administration) in the development of unwanted immune responses have utilized one of a variety of mouse models. In this review, we discuss the utility and drawbacks of different mouse models that have been used for this purpose. Moreover, we summarize the lessons these models have taught us and some of the challenges they present. Finally, we provide recommendations for future research utilizing mouse models to improve our understanding of critical factors that may contribute to protein immunogenicity.

Indexed as

Models, AnimalAnimalsAntibody FormationHumansImmunogenetic PhenomenaImmunoglobulin GImmunoproteinsMiceMice, TransgenicProtein AggregatesSpecies SpecificityImmunoglobulin GImmunoproteinsProtein Aggregatesimmunogenicityin vivo modelsprotein aggregation

Identifiers

PMID27044944
PMCPMC4846475

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.