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Benchmarking Protein Nanoparticles for Drug Delivery and Clinical Translation.

Han Sol Lee1, Suwon Choo2, Mansingh Chaudhary3

  • 1College of Pharmacy and Research Institute of Pharmaceutical Sciences (RIPS), Chosun University, Gwangju, Republic of Korea.

Small Methods
|December 26, 2025
PubMed
Summary

Protein nanoparticles (PNs) offer biocompatible drug delivery solutions with tunable properties for enhanced stability and targeted cancer therapy. Further research and standardized evaluations are needed for broader clinical application.

Keywords:
cancer nanomedicineclinical translationevaluation methodsfunctionalization strategiesprotein nanoparticles

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Area of Science:

  • Biomaterials Science
  • Nanotechnology
  • Pharmaceutical Sciences

Background:

  • Protein nanoparticles (PNs) are biocompatible drug delivery platforms with inherent biodegradability and specificity.
  • Their tunable structure and properties make them promising for targeted cancer nanomedicine.

Purpose of the Study:

  • To review the classification, fabrication, functionalization, and evaluation of protein nanoparticles for drug delivery.
  • To highlight challenges and opportunities in the development of protein nanomedicines.

Main Methods:

  • Classification of PNs into native-ordered, native-amorphous, and denatured categories.
  • Discussion of fabrication techniques (emulsification, crosslinking, desolvation) and functionalization strategies (PEGylation, Fc fusion, lipidation).
  • Emphasis on a systematic evaluation framework including physicochemical characterization, in vitro, and in vivo assays.

Main Results:

  • PNs can improve drug stability, prolong circulation time, and enable targeted delivery, enhancing therapeutic efficacy.
  • Functionalization strategies like PEGylation and lipidation improve tumor selectivity.
  • Nab-paclitaxel and virus-like particle (VLP) vaccines showcase PN potential in clinical settings.

Conclusions:

  • Protein nanoparticles represent a promising frontier in nanomedicine, particularly for cancer therapy.
  • Standardized evaluation methods and regulatory guidelines are crucial for clinical translation.
  • Innovation in fabrication and functionalization will drive the next generation of protein nanomedicines.