Cited by 302Nanoparticle-Based Drug DeliveryAdvanced Drug Delivery SystemsPharmacology and Nanomedicine Research

PLGA-based nanomedicines manufacturing: Technologies overview and challenges in industrial scale-up

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Operti, Maria Camilla, Bernhardt, Alexander, Grimm, Silko, Engel, Andrea, Figdor, Carl Gustav, Tagit, Oya·2021·International Journal of Pharmaceutics

Abstract

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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Crossref · 10.1016/j.ijpharm.2021.120807

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130 of 130 references verified0 citation errors · 0 not checkable

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  • Challenges arise when moving from benchtop to large-scale production because the efficacy, safety, and drug delivery characteristics of each 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 process.

    “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”
  • No PLGA nanomedicine formulation is currently available on the global market.

    “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”

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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
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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