ReviewTranslational research : the journal of laboratory and clinical medicine2022
Development of mRNA manufacturing for vaccines and therapeutics: mRNA platform requirements and development of a scalable production process to support early phase clinical trials.
Review in Translational research : the journal of laboratory and clinical medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 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
79 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
- IntegratedMolecular therapy. Nucleic acids · 2026Article
- Self-amplifying RNA (saRNA) and circular RNA (circRNA) vaccines: Progress, evidence gaps, and translational pathways for durable and scalable immunization.Human vaccines & immunotherapeutics · 2026Review
- Bioengineering strategies for improving the immunogenicity of mRNA vaccines.Signal transduction and targeted therapy · 2026Review
- Beyond the genetic code: orchestrating epigenetic and immune landscapes with multivalent mRNA-exosome vaccines.Precision clinical medicine · 2026Review
- Bacterial mRNA Vaccines: Programming Immunity Against Antimicrobial Resistance.Drug development research · 2026Review
- IVT-free, chemically synthesized protein-encoding RNA oligonucleotides for rapid production of personalized cancer vaccines.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Design, Synthesis, and Proof-of-Concept Bioassay of an Encapsulated mRNA for Human Growth Hormone.Current issues in molecular biology · 2026Article
- Recent advances in lipid nanoparticles for cancer vaccine delivery: Challenges and future perspectives.International journal of pharmaceutics: X · 2026Review
- Circular RNA vaccines encoding fusion proteins of Mpox Virus A35R-M1R and B6R-A29L induce robust and durable protective immunity in mice.Journal of nanobiotechnology · 2026Article
- Emerging Non-Conventional Approaches in mRNA-LNP Formulation for Therapeutic Applications.Pharmaceutics · 2026Review
- Recent advances in lipid and biomimetic nanocarriers for nucleic acid delivery in glioblastoma.Discover oncology · 2026Review
- Review
- One-component ionizable amphiphilic Janus dendrimers as a delivery platform for efficient mRNA vaccine development.Science advances · 2026Article
- Ambient-Stable mRNA Medicines: Emerging Paradigms in Dry and Solid-State Formulation.Pharmaceuticals (Basel, Switzerland) · 2026Review
- mRNA-Encoded Antibodies: An Emerging Paradigm in Antiviral Protection.Biomolecules · 2026Review
- Process and analytical strategies for the safe production of mRNA vaccines and therapeutics.Molecular biology reports · 2026Review
- mRNA-Encoded antibodies as a next-generation therapeutic paradigm: a rapid and adaptive platform for the prevention and treatment of emerging and re-emerging infectious diseases - A critical review.Immunologic research · 2026Review
- Updated profiling of COVID-19 vaccine adverse events using VAERS case reports.Frontiers in pharmacology · 2026Article
- In-process analytics for IVT mRNA manufacturing: from process understanding to advanced process control.Frontiers in bioengineering and biotechnology · 2026Review
19 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
33 authors.
Funding
Abstract
The remarkable success of SARS CoV-2 mRNA-based vaccines and the ensuing interest in mRNA vaccines and therapeutics have highlighted the need for a scalable clinical-enabling manufacturing process to produce such products, and robust analytical methods to demonstrate safety, potency, and purity. To date, production processes have either not been disclosed or are bench-scale in nature and cannot be readily adapted to clinical and commercial scale production. To address these needs, we have advanced an aqueous-based scalable process that is readily adaptable to GMP-compliant manufacturing, and developed the required analytical methods for product characterization, quality control release, and stability testing. We also have demonstrated the products produced at manufacturing scale under such approaches display good potency and protection in relevant animal models with mRNA products encoding both vaccine immunogens and antibodies. Finally, we discuss continued challenges in raw material identification, sourcing and supply, and the cold chain requirements for mRNA therapeutic and vaccine products. While ultimate solutions have yet to be elucidated, we discuss approaches that can be taken that are aligned with regulatory guidance.
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.