Abstract
It is a major challenge to produce proof-of-concept (PoC) pharmaceutical nanoformulations of the required quality level, and in sufficient quantities for late preclinical and clinical testing. The creation of bespoke capabilities to assist in the translation of early stage PoC medicines could greatly reduce time and cost to bring new and innovative therapies to the market. This paper reflects on current barriers hampering the commercialization of novel nanopharmaceuticals and discusses the potential for integrated approaches to bring together existing and new processing infrastructures to de-risk and accelerate the development, manufacturing and market entry of the next-generation nanopharmaceuticals.
| Original language | English |
|---|---|
| Article number | 104433 |
| Journal | Drug Discovery Today |
| Volume | 30 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - Aug 2025 |
Keywords
- critical quality attributes
- drug nanoparticles
- GMP
- nanopharmaceutical development hubs
- nanopharmaceuticals
- scale-up