Nanomedicine has attracted significant interest across various disciplines due to its vast potential applications. In particular, medical research has heavily invested in nanomaterials to develop innovative solutions for disease treatment and diagnosis [1].

The rapid integration of nanomedicines into research and clinical applications has led to the approval of numerous products by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). However, the regulatory framework for polymeric nanomaterials in medicine remains underdeveloped, highlighting the urgent need for specific guidelines tailored to nanoscale materials [2].

This study focuses on the synthesis of polymeric nanoparticles based on amphiphilic copolymers with complex architectures, serving as a case study to identify key regulatory challenges and critical issues associated with nanomedicines, particularly concerning nanoscale properties, manufacturing and nanotoxicology. By addressing these challenges, this work aims to support future nanomedicine developers throughout the entire pipeline, from initial formulation to market approval.

A diverse library of amphiphilic copolymers with varying compositions and architectures was synthesized using Ring-Opening Polymerization (ROP) and Atom Transfer Radical Polymerization (ATRP) [3]. Polymeric nanoparticles were then formulated via nanoprecipitation and loaded with a model drug. This stage established the foundation for polymer-based nanomedicine design, initial characterization, and formulation development, setting the stage for further optimization.

To ensure regulatory compliance, standardized protocols will be developed, aligning all processes with safety, efficacy, and quality requirements. This approach will facilitate the translation of nanomedicines from bench to bedside, addressing existing regulatory gaps and paving the way for safer and more effective nanotherapeutics.

References

1. S. Malik, K. Muhammad, Y. Waheed Molecules 2023, 28, 661.
2. A.V. Singh, P. Laux, A. Luch, C. Sudrik, S. Wiehr, A.M. Wild, G. Santomauro, J. Bill, M. Sitti Toxicol. Mech. Methods 2019, 29, 378.
3. I. Porello, F. Stucchi, G. Sbaruffati, F. Cellesi Eur. Polym. J. 2024, 220, 113455.