ArticleJournal of controlled release : official journal of the Controlled Release Society2021
Pilot-scale production of expansile nanoparticles: Practical methods for clinical scale-up.
Article in Journal of controlled release : official journal of the Controlled Release Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
20 citing papers in PubMed.
- From bench to bulk: exploring in-line homogenization for scale-up and continuous production of vesicular systems.Drug delivery and translational research · 2026Article
- Nanoparticle-Based Radiosensitization in Breast Cancer: A Multimodal Approach to Therapy and Immune Regulation.Biotechnology journal · 2026Review
- Article
- Nano-antioxidants for neurodegenerative disorders: a scoping review.Discover nano · 2025Review
- Nanocarrier-Based Systems for Targeted Delivery: Current Challenges and Future Directions.MedComm · 2025Review
- Oxymatrine and astragaloside IV co-loaded liposomes: Scale-up purposes and their enhancement of anti-PD-1 efficacy against breast cancer.Materials today. Bio · 2025Article
- For and against tumor microenvironment: Nanoparticle-based strategies for active cancer therapy.Materials today. Bio · 2025Review
- Nano-healing: Exploring the Therapeutic Potentials of Nanomedicine for CNS Disorders.Current pharmaceutical design · 2025Review
- Recent advances in the bench-to-bedside translation of cancer nanomedicines.Acta pharmaceutica Sinica. B · 2025Review
- Metal Peroxide Nanoparticles for Modulating the Tumor Microenvironment: Current Status and Recent Prospects.Cancers · 2024Review
- Unveiling the Performance of Co-Assembled Hybrid Nanocarriers: Moving towards the Formation of a Multifunctional Lipid/Random Copolymer Nanoplatform.Pharmaceutics · 2024Article
- Engineered nanoparticles for precise targeted drug delivery and enhanced therapeutic efficacy in cancer immunotherapy.Acta pharmaceutica Sinica. B · 2024Review
- Deciphering the Lipid-Random Copolymer Interactions and Encoding Their Properties to Design a Hybrid System.Langmuir : the ACS journal of surfaces and colloids · 2024Article
- Harnessing nanotechnology for cancer treatment.Frontiers in bioengineering and biotechnology · 2024Review
- Polymeric Nanoparticles for Delivery of Natural Bioactive Agents: Recent Advances and Challenges.Polymers · 2023Review
- Radiolabeled Biodistribution of Expansile Nanoparticles: Intraperitoneal Administration Results in Tumor Specific Accumulation.ACS nano · 2023Article
- pH-Responsive nanofiber buttresses as local drug delivery devices.Biomaterials science · 2023Article
- Review
- Preparation and Characterization of a Novel Multiparticulate Dosage Form Carrying Budesonide-Loaded Chitosan Nanoparticles to Enhance the Efficiency of Pellets in the Colon.Pharmaceutics · 2022Article
- Prussian Blue Nanozymes with Enhanced Catalytic Activity: Size Tuning and Application in ELISA-like Immunoassay.Nanomaterials (Basel, Switzerland) · 2022Article
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
One of the foremost challenges in translating nanoparticle technologies to the clinic is the requirement to produce materials on a large-scale. Scaling nanoparticle production methods is often non-trivial, and the success of these endeavors is frequently governed by whether or not an intermediate level of production, i.e., "pilot-scale" production, can be achieved. Pilot-scale production at the one-liter scale serves as a proof-of-concept that large-scale production will be possible. Here, we describe the pilot-scale production of the expansile nanoparticle (eNP) technology including verification of activity and efficacy following scaleup. We describe the challenges of sonication-based emulsification procedures and how these were overcome by use of a Microfluidizer technology. We also describe the problem-solving process that led to pre-polymerization of the nanoparticle polymer-a fundamental change from the lab-scale and previously published methods. Furthermore, we demonstrate good control over particle diameter, polydispersity and drug loading and the ability to sterilize the particles via filtration using this method. To facilitate long-term storage of these larger quantities of particles, we investigated six lyoprotectants and determined that sucrose is the most compatible with the current system. Lastly, we demonstrate that these changes to the manufacturing method do not adversely affect the swelling functionality of the particles, their highly specific localization to tumors, their non-toxicity in vivo or their efficacy in treating established intraperitoneal mesothelioma xenografts.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.