Background <p>Therapeutic proteins are playing an increasingly important role in marketed drugs and clinical candidates. However, their development still faces major challenges, particularly aggregation.</p> Objectives <p>This review explores the recent advancements, current limitations, and future directions of new research methods for therapeutic proteins.</p> Results <p>Characterization techniques identify aggregation tendencies and elucidate underlying mechanisms, while computational chemistry provides microscopic insights into the aggregation process. Theoretical modeling and machine learning offer tools for predicting protein stability, enabling high-throughput screening in early formulation development.</p> Conclusion <p>Fostering interdisciplinary collaboration will be essential. The integration of diverse approaches offers a more comprehensive understanding of protein aggregation and unlocks new opportunities for innovation in protein formulation development.</p>

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Emerging Technologies and Integrated Interdisciplinary Strategies for Mitigating Protein Aggregation in Therapeutic Formulations

  • Haomin Wu,
  • QinXi Fan,
  • Zheng Zhang,
  • Yuanhui Ji

摘要

Background

Therapeutic proteins are playing an increasingly important role in marketed drugs and clinical candidates. However, their development still faces major challenges, particularly aggregation.

Objectives

This review explores the recent advancements, current limitations, and future directions of new research methods for therapeutic proteins.

Results

Characterization techniques identify aggregation tendencies and elucidate underlying mechanisms, while computational chemistry provides microscopic insights into the aggregation process. Theoretical modeling and machine learning offer tools for predicting protein stability, enabling high-throughput screening in early formulation development.

Conclusion

Fostering interdisciplinary collaboration will be essential. The integration of diverse approaches offers a more comprehensive understanding of protein aggregation and unlocks new opportunities for innovation in protein formulation development.