ArticleScientific reports2024
Impact of mixing and shaking on mRNA-LNP drug product quality characteristics.
Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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The trial behind it
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Who cites it
14 citing papers in PubMed.
- Advancements of mRNA-lipid nanoparticle links to gene editing and immune responses.Journal, genetic engineering & biotechnology · 2026Review
- Comprehensive Analytical Characterization of mRNA Influenza Vaccine Under Stress Conditions: Implications for Stability and Quality Control.Pharmaceutical research · 2026Article
- 3D-Printed Milli-Fluidic Mixing-Extrusion Platform for Continuous, High-Throughput LNP Production.Small (Weinheim an der Bergstrasse, Germany) · 2026Article
- Analytical Characterization and Stability Assessment of RNA-Based Vaccines.Pharmaceutics · 2026Review
- Industrial Perspective on the Manufacturing of Lipid Nanoparticles for Nucleic Acid Delivery.Pharmaceutics · 2026Review
- Programmable lipid nanoparticles for RNA therapeutics: Design principles and clinical translation.Materials today. Bio · 2026Review
- Lipid Nanoparticle Development in Practice: Challenges and Collective Insights.Pharmaceutical research · 2026Review
- Pulmonary delivery of siRNA lipoplexes and lipid nanoparticles using a vibrating mesh nebuliser.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2026Article
- Elucidating the underlying mechanism of mechanical stress-induced impact on mRNA-LNP structure.Scientific reports · 2025Article
- Process Analytical Strategies for Size Monitoring: Offline, At-Line, Online, and Inline Methods in a Top-Down Nano-Manufacturing Line.Pharmaceutics · 2025Article
- Current and Near-Future Technologies to Quantify Nanoparticle Therapeutic Loading Efficiency and Surface Coating Efficiency with Targeted Moieties.Bioengineering (Basel, Switzerland) · 2025Review
- A novel in-vitro expression assay by LC/MS/MS enables multi-antigen mRNA vaccine characterization.Scientific reports · 2025Article
- RNA Stability: A Review of the Role of Structural Features and Environmental Conditions.Molecules (Basel, Switzerland) · 2024Review
- 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
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Since the COVID-19 pandemic, the interest in RNA-lipid nanoparticle (LNP) based drug products has increased drastically. While one RNA-LNP drug product, Onpattro, was already on the market in 2018, high volume manufacturing was only initiated end of 2020 with the approval of the mRNA-LNP vaccines, Comirnaty and Spikevax. As such, deep product knowledge for RNA-LNPs is continuously increasing. In this article the effect of large-scale mixing and lab-scale shaking on mRNA-LNP drug product quality characteristics is investigated. It is shown that mixing and shaking can have a profound impact on both LNP size distribution and mRNA encapsulation, suggesting a direct correlation between both quality characteristics, and further supported by a proposed underlying mechanism. An in-depth investigation of different drug product (DP) presentations reveals a consistent effect of headspace volume and LNP content on the shaking stress sensitivity. Results reported in this study are of utter importance for both small- and large-scale manufacturers but also for care givers and patients using these products.
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Registered trials
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