ReviewVaccines2024
The Platform Technology Approach to mRNA Product Development and Regulation.
Review in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Framework to identify innovative sources of value creation from platform technologies.Proceedings of the National Academy of Sciences of the United States of America · 2025Pooled it
- Targeted delivery of mRNA to immune cells forDrug delivery · 2026Review
- mRNA Therapeutics Beyond Infectious Diseases: Expanding Therapeutic Applications and Future Perspectives.Immunity, inflammation and disease · 2026Review
- Article
- Emerging Non-Conventional Approaches in mRNA-LNP Formulation for Therapeutic Applications.Pharmaceutics · 2026Review
- Next-generation neoantigen mRNA vaccines: Immuno-engineering strategies for precision cancer immunotherapy.Cellular oncology (Dordrecht, Netherlands) · 2026Review
- RNA-Based Therapies for Inherited Metabolic Disorders.Journal of inherited metabolic disease · 2026Review
- Ambient-Stable mRNA Medicines: Emerging Paradigms in Dry and Solid-State Formulation.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Article
- A Comprehensive Review of Vaccine Development: From Traditional Platforms to Messenger RNA (mRNA) Technologies.Cureus · 2026Review
- Precision Engineering of Extracellular Vesicles as Programmable Carriers for mRNA Therapeutics.International journal of nanomedicine · 2026Review
- The mRNA-1647 vaccine: A promising step toward the prevention of cytomegalovirus infection (CMV).Human vaccines & immunotherapeutics · 2025Review
- Engineered chimeric T7 RNA polymerase improves salt tolerance and reduces dsRNA impurity generation during in vitro transcription of mRNA.Nucleic acids research · 2025Article
- Strengthening the Use of International Collaborative Regulatory Assessments and Regulatory Alignment- Implications for Global Convergence.Therapeutic innovation & regulatory science · 2025Review
- Considerations for mRNA Product Development, Regulation and Deployment Across the Lifecycle.Vaccines · 2025Review
- Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China.Vaccines · 2024Article
- The Impact of COVID-19 on RNA Therapeutics: A Surge in Lipid Nanoparticles and Alternative Delivery Systems.Pharmaceutics · 2024Review
- From roadmap to a sustainable end-to-end individualized therapy pathway.Therapeutic advances in rare diseaseReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
mRNA-lipid nanoparticle (LNP) medicinal products can be considered a platform technology because the development process is similar for different diseases and conditions, with similar noncoding mRNA sequences and lipid nanoparticles and essentially unchanged manufacturing and analytical methods often utilised for different products. It is critical not to lose the momentum built using the platform approach during the development, regulatory approval and rollout of vaccines for SARS-CoV-2 and its variants. This review proposes a set of modifications to existing regulatory requirements for mRNA products, based on a platform perspective for quality, manufacturing, preclinical, and clinical data. For the first time, we address development and potential regulatory requirements when the mRNA sequences and LNP composition vary in different products as well. In addition, we propose considerations for self-amplifying mRNA, individualised oncology mRNA products, and mRNA therapeutics. Providing a predictable development pathway for academic and commercial groups so that they can know in detail what product characterisation and data are required to develop a dossier for regulatory submission has many potential benefits. These include: reduced development and regulatory costs; faster consumer/patient access and more agile development of products in the face of pandemics; and for rare diseases where alternatives may not exist or to increase survival and the quality of life in cancer patients. Therefore, achieving consensus around platform approaches is both urgent and important. This approach with mRNA can be a template for similar platform frameworks for other therapeutics and vaccines to enable more efficient development and regulatory review.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.