Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 605, Issue -, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.ijpharm.2021.120807
Keywords
Nanomedicine; PLGA; Nanoparticles; Scale-up manufacturing; Clinical translation
Categories
Funding
- European Union [686089]
- NWO Spinoza grant
- ERC Advanced Grant Pathfinder [269019]
- Dutch cancer society [2009-4402]
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Nanomedicines based on PLGA carriers show great potential for biomedical research, but are not yet available on the global market. Challenges include scaling up production and successful translation into clinical practice, requiring advancements in manufacturing techniques and quality control methods.
Nanomedicines based on poly(lactic-co-glycolic acid) (PLGA) carriers offer tremendous opportunities for biomedical research. Although several PLGA-based systems have already been approved by both the Food and Drug Administration (FDA) and the European Medicine Agency (EMA), and are widely used in the clinics for the treatment or diagnosis of diseases, no PLGA nanomedicine formulation is currently available on the global market. One of the most impeding barriers is the development of a manufacturing technique that allows for the transfer of nanomedicine production from the laboratory to an industrial scale with proper characterization and quality control methods. This review provides a comprehensive overview of the technologies currently available for the manufacturing and analysis of polymeric nanomedicines based on PLGA nanoparticles, the scale-up challenges that hinder their industrial applicability, and the issues associated with their successful translation into clinical practice.
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