ReviewWiley interdisciplinary reviews. Nanomedicine and nanobiotechnology
Drug Product Development of Lipid Nanoparticle-Based mRNA Therapeutics and Vaccines.
Review in Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- Next-Generation Nanocarrier Platforms for RNA Vaccines: Advances in Formulation, Stability Engineering, and Translational Manufacturing Challenges.Pharmaceutics · 2026Review
- Industrial Perspective on the Manufacturing of Lipid Nanoparticles for Nucleic Acid Delivery.Pharmaceutics · 2026Review
- Drug Product Development of Lipid Nanoparticle-Based mRNA Therapeutics and Vaccines.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Lipid nanoparticles (LNP) are currently the most relevant non-viral delivery systems for mRNA and occasionally for smaller nucleic acids such as small interfering RNA. Although the manufacturing of LNP is well established and scalable equipment is available for production, LNP drug product development is not straightforward. Numerous factors influence product quality, including LNP composition, process parameters, and formulation composition. A proper understanding and control of the critical variables is essential for product development of LNP containing pharmaceuticals. This article provides an overview on the drug product development roadmap for LNP-based therapeutics and vaccines. Based on the quality target product profile and current scientific and technical knowledge, key aspects that may impact product quality will be discussed. Strategies to identify failure risks as early in the development process as possible and ways to mitigate them will be addressed. The majority of steps in the development are covered, including LNP design and LNP manufacturing process, analytical development, and formulation development to achieve a stable and safe product suitable for human application. This article is categorized under: Biology-Inspired Nanomaterials > Lipid-Based Structures.
Indexed as
Identifiers
What Socratic holds
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 Socratic graph.