The DOI matches its Crossref record; 129 of the 134 references it cites were found in a registry or an index.
PLGA-based nanomedicines manufacturing: Technologies overview and challenges in industrial scale-up
Open accessAbstract
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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“Challenges arise when moving from benchtop to large-scale production because, unlike the conventional drug products, the efficacy and safety, as well as the unique drug delivery characteristics of each individual nanomedicine formulation, are a direct consequence of the physicochemical properties of the nanoparticles that carry the drug, which can be altered when adopting a larger scale production”
From Off-label and repurposed use of disulfiram beyond alcohol dependence: A systematic review of clinical and preclinical evidence (2026) · cites this paper as [154]
In the citing paper
“Several PLGA-based systems have already been approved by both the FDA and the European Medicines Agency (EMA) and are widely used in clinics for the treatment or diagnosis of diseases, no PLGA nanomedicine formulation is currently available on the global market.154,155”
From Off-label and repurposed use of disulfiram beyond alcohol dependence: A systematic review of clinical and preclinical evidence (2026) · cites this paper as [154]
Citations
Cites
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Cited by
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Items 301–303 of 303
Advances and challenges in inner ear drug delivery: limitations and therapeutic perspectives
Cervantes, B., Murillo‐Cuesta, S., Zubeldia, J. M., Castro, A., & Varela‐Nieto, I. (2026) · Expert Opinion on Drug Delivery · doi:10.1080/17425247.2026.2748110
Kumar, A., Patel, M., Swaroop, M., Tiwari, R. K., & Yadav, N. (2026) · IntechOpen eBooks · doi:10.5772/intechopen.1018234
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Metadata
- Authors
- Operti, M. C., Bernhardt, A., Grimm, S., Engel, A., Figdor, C. G., & Tagit, O.
- Affiliations
- Radboud University Nijmegen (NL)
- Corresponding author
- Tagit, Oya
- Venue
- International Journal of Pharmaceutics
- Publisher
- Elsevier BV
- Published
- 2021-08
- Volume
- 605
- Pages
- 120807
- ISSN
- 0378-5173 (ISSN-L)
- OpenAlex
- W3171433358
- Cited by
- 302
- References
- 134
- Citations by year
- 2026: 60 · 2025: 79 · 2024: 56 · 2023: 61 · 2022: 38 · 2021: 8
- FWCI
- 2.82
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- International Journal of Pharmaceutics (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion, other-oa)
- Funders
- European Commission (HORIZON2020, 686089)
- Nederlandse Organisatie voor Wetenschappelijk Onderzoek (269019)
- Topics
- Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Drug Discovery › Pharmacology and Nanomedicine Research
- Keywords
- PLGA nanoparticles, nanomedicine manufacturing, industrial scale-up, polymeric drug carriers, quality control, clinical translation, biodegradable polymers, drug delivery systems
- MeSH terms
- Industry, Nanomedicine, Nanoparticles
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