ArticleScientific reports2022
DoE-derived continuous and robust process for manufacturing of pharmaceutical-grade wide-range LNPs for RNA-vaccine/drug delivery.
Article in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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
18 citing papers in PubMed.
- Next-Generation Nanocarrier Platforms for RNA Vaccines: Advances in Formulation, Stability Engineering, and Translational Manufacturing Challenges.Pharmaceutics · 2026Review
- Microfluidic-Driven Assembly of RNA Nanocomplexes: Design, Process Control and Translational Perspectives in Oncology.Pharmaceutics · 2026Review
- The application of nanoparticle-mediated siRNA delivery systems in ovarian cancer.Cancer gene therapy · 2026Review
- Recent advances in lipid and biomimetic nanocarriers for nucleic acid delivery in glioblastoma.Discover oncology · 2026Review
- From RNA to DNA: How Cargo Identity Reprograms Lipid Nanoparticle Architecture and Function.Advanced healthcare materials · 2026Review
- QbD product development: rapid optimization and scale-up of PBAE-based siRNA deliveryRSC pharmaceutics · 2026Article
- Continuous Microfluidic Manufacture of Nano-in-Microparticles Combining 3D-Printed Micromixers and Spray Drying.Pharmaceutical research · 2026Article
- Smart Colloidal Systems as Drug Delivery and Therapeutic Modulation Platforms for Renal Cell Carcinoma.International journal of nanomedicine · 2026Review
- On-Chip De Novo Production of mRNA Vaccine in Lipid Nanoparticles.Small (Weinheim an der Bergstrasse, Germany) · 2025Article
- Optimization of a Dissolvable Lipid Nanoparticle Microneedle Formulation for mRNA Delivery Using Design of Experiments.ACS applied materials & interfaces · 2025Article
- Advancing Cancer Immunotherapy Using Lipid Nanoparticle-Based Approaches.International journal of nanomedicine · 2025Review
- Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China.Vaccines · 2024Article
- Quality by design for mRNA platform purification based on continuous oligo-dT chromatography.Molecular therapy. Nucleic acids · 2024Article
- Machine learning-driven optimization of mRNA-lipid nanoparticle vaccine quality with XGBoost/Bayesian method and ensemble model approaches.Journal of pharmaceutical analysis · 2024Article
- Toward a large-batch manufacturing process for silicon-stabilized lipid nanoparticles: A highly customizable RNA delivery platform.Molecular therapy. Methods & clinical development · 2024Article
- Effect of Micromixer Design on Lipid Nanocarriers Manufacturing for the Delivery of Proteins and Nucleic Acids.Pharmaceutics · 2024Article
- Quality by Design (QbD) and Design of Experiments (DOE) as a Strategy for Tuning Lipid Nanoparticle Formulations for RNA Delivery.Biomedicines · 2023Review
- Drug Product Development of Lipid Nanoparticle-Based mRNA Therapeutics and Vaccines.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnologyReview
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Lipid nanoparticle (LNP) technology has become extremely demanding for delivering RNA-products and other drugs. However, there is no platform to manufacture pharmaceutical-grade LNPs with desired particle size from a wide range in continuous mode. We have developed a unique platform to obtain any specific size-range of LNPs from 60 to 180 nm satisfying pharmaceutical regulatory requirements for polydispersity index, sterility, dose uniformity and bio-functionality. We applied design of experiment (DoE) methodology and identified the critical process parameters to establish the process for global application. Cross-point validation within the response map of DoE confirmed that the platform is robust to produce specific size (± 10 nm) of LNPs within the design-range. The technology is successfully transformed to production scale and validated. Products from R&D, pilot and production batches for a candidate SARS-CoV-2 mRNA-vaccine generated equivalent biological responses. The data collectively established the robustness and bio-uniformity of doses for global RNA-vaccine/drug formulation.
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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.