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Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges.

Wim Jiskoot1, Grzegorz Kijanka1, Theodore W Randolph2

  • 1Division of Drug Delivery Technology, Leiden Academic Centre for Drug Research, Leiden University, P.O. Box 9502, RA Leiden 2300, The Netherlands.

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Summary
This summary is machine-generated.

Mouse models are crucial for studying therapeutic protein immunogenicity, but their limitations require careful consideration. This review evaluates their utility and drawbacks to guide future research on protein drug safety.

Keywords:
immunogenicityin vivo modelsprotein aggregation

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Area of Science:

  • Biotechnology
  • Immunology
  • Pharmacology

Background:

  • Therapeutic proteins are increasingly successful but can cause adverse immune responses.
  • Product attributes (aggregates, particles) and administration (dose, schedule, route) influence immunogenicity.
  • Mouse models are commonly used to study these factors.

Purpose of the Study:

  • To review the utility and limitations of mouse models for assessing protein immunogenicity.
  • To summarize key findings and challenges from studies using these models.
  • To provide recommendations for future research directions.

Main Methods:

  • Literature review of studies employing mouse models to investigate protein immunogenicity.
  • Analysis of product-related attributes and treatment regimens in relation to immune responses.
  • Evaluation of the strengths and weaknesses of various mouse models used.

Main Results:

  • Mouse models have provided valuable insights into factors driving protein immunogenicity.
  • Different models exhibit varying degrees of predictive power and applicability.
  • Challenges include model-specific responses and translation to human outcomes.

Conclusions:

  • Mouse models are indispensable tools for understanding protein immunogenicity.
  • Selecting appropriate models and interpreting results critically is essential.
  • Future research should focus on refining models and addressing current limitations for improved drug safety.