Mouse Models for Assessing Protein Immunogenicity: Lessons and Challenges

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.