Tools for translation: non-viral materials for therapeutic mRNA delivery

Hajj, Khalid A.; Whitehead, Kathryn A.

doi:10.1038/natrevmats.2017.56

Cited by 799RNA Interference and Gene DeliveryNanoparticle-Based Drug DeliveryRNA and protein synthesis mechanisms

Tools for translation: non-viral materials for therapeutic mRNA delivery

Hajj, Khalid A., Whitehead, Kathryn A.·2017·Nature Reviews Materials

DOI 10.1038/natrevmats.2017.56

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To maximize translation, the mRNA sequence typically incorporates modified nucleosides, such as pseudouridine, N1-methylpseudouridine or other nucleoside analogues.
“To maximize translation, the mRNA sequence typically incorporates modified nucleosides, such as pseudouridine, N1-methylpseudouridine or other nucleoside analogues23.”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [23]
mRNA has therapeutic potential in viral vaccines, protein replacement therapies, cancer immunotherapies, cellular reprogramming and genome editing.
“mRNA has shown therapeutic potential in a range of applications, including viral vaccines, protein replacement therapies, cancer immunotherapies, cellular reprogramming and genome editing2,4,7–17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
These other lipids can improve nanoparticle properties, such as particle stability, delivery efficacy, tolerability and biodistribution.
“These lipids can improve nanoparticle properties, such as particle stability, delivery efficacy, tolerability and biodistribution7,14,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
Trapped in endosomes, ionizable lipids are protonated and become positively charged, which may promote membrane destabilization and facilitate endosomal escape.
“Trapped in endosomes, in which the pH is lower than in the extracellular environment, ionizable lipids are protonated and, therefore, become positively charged, which may promote membrane destabilization and facilitate endosomal escape of the nanoparticles7,11,14”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
To function in vivo, lipid nanoparticle-mRNA formulations need to overcome multiple extracellular and intracellular barriers.
“To function in vivo, lipid nanoparticle–mRNA formulations need to overcome multiple extracellular and intracellular barriers7,11 (Fig. 3a).”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]

Lipid nanoparticle-mRNA formulations typically contain other lipid components, such as phospholipids, cholesterol or PEG-lipids.
“In addition to cationic or ionizable lipids, lipid nanoparticle–mRNA formulations typically contain other lipid components, such as phospholipids (for example, phosphatidylcholine and phosphatidylethanolamine), cholesterol or polyethylene glycol (PEG)-functionalized lipids (PEG-lipids)7,14,17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
The pH-sensitivity of ionizable lipids is beneficial for mRNA delivery in vivo because neutral lipids have less interactions with anionic membranes of blood cells and improve biocompatibility.
“The pH-sensitivity of ionizable lipids is beneficial for mRNA delivery in vivo, because neutral lipids have less interactions with the anionic membranes of blood cells and, thus, improve the biocompatibility of lipid nanoparticles7,11,14.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
mRNA normally contains five structural elements: a 5′ cap, a 3′ poly(A) tail, a protein-coding sequence and 5′ and 3′ untranslated regions.
“mRNA normally contains five structural elements, that is, a 5′ cap, a 3′ poly(A) tail, a protein-coding sequence and 5′ and 3′ untranslated regions (UTRs)2,4,7,13.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
These elements can be engineered to improve the stability and translational efficiency of mRNA.
“These elements can be engineered to improve the stability and translational efficiency of mRNA2,4,7,13.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
Chemical modifications of specific IVT mRNA nucleotides, such as pseudouridine (ψ) and N1-methylpseudouridine (m1ψ), can reduce innate immune sensing of exogenous mRNA translation.
“Chemical modifications of specific IVT mRNA nucleotides, such as pseudouridine (ψ) and N1-methylpseudouridine (m1ψ), can reduce innate immune sensing of exogenous mRNA translation2,4,7,182.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
Chromatographic purification can remove double-stranded RNA in IVT mRNA preparations, diminishing immune activation and increasing translational efficiency.
“Chromatographic purification can remove double-stranded RNA, an analogue of viral genome, in IVT mRNA preparations, diminishing immune activation and increasing translational efficiency2,4,7,183.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
Engineering of mRNA molecules and design of lipid nanoparticles have been optimized, contributing to the rapid development and clinical assessment of the two COVID-19 mRNA vaccines.
“To address these concerns, the engineering of mRNA molecules (Box 1) and the design of lipid nanoparticles have been optimized2,4,7–17, which has contributed to the rapid development and clinical assessment15,17 of the two COVID-19 mRNA vaccines, mRNA-1273 (NCT04470427)19,20 and BNT162b2 (NCT04368728)21.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
Polymers such as polyethyleneimine, protamine and polyaspartamide derivatives are already widely used for mRNA delivery.
“Polymers, such as polyethyleneimine, protamine and polyaspartamide derivatives, are already widely used for mRNA delivery7–17.”
From Lipid nanoparticles for mRNA delivery (2021) · cites this paper as [7]
mRNA functions as the bridge between DNA and proteins in eukaryotic cells.
“mRNA functions as the bridge between DNA and proteins in eukaryotic cells.[8, 12, 119]”
From RNA delivery biomaterials for the treatment of genetic and rare diseases (2019) · cites this paper as [8]
PEI's toxicity has limited its therapeutic applications.
“Polyethylenimine (PEI) is one of the most developed cationic polymers [39], but its toxicity has limited the therapeutic applications.[8, 124]”
From RNA delivery biomaterials for the treatment of genetic and rare diseases (2019) · cites this paper as [8]
Compared with protein drugs, mRNA can supplement both cytoplasmic and large transmembranic proteins.
“Compared with protein drugs, mRNA can supplement both cytoplasmic and large transmembranic proteins.[8, 119, 120]”
From RNA delivery biomaterials for the treatment of genetic and rare diseases (2019) · cites this paper as [8]
Many biomaterials have been developed for mRNA delivery, including lipids and lipid derived materials, polymers, and many others.
“Recently, many biomaterials have been developed for mRNA delivery, including lipids and lipid derived materials, polymers, and many others. [8, 39, 120, 124]”
From RNA delivery biomaterials for the treatment of genetic and rare diseases (2019) · cites this paper as [8]
Relative to plasmid DNA, mRNA possesses temporary bioactivity and functions outside the nucleus, leading to more controllable protein expression and avoiding potential insertion of the genome.
“Relative to plasmid DNA (pDNA), mRNA possesses temporary bioactivity and functions outside the nucleus, leading to a more controllable protein expression and avoiding the potential insertion of the genome.[8, 119, 120]”
From RNA delivery biomaterials for the treatment of genetic and rare diseases (2019) · cites this paper as [8]
For many GARDs, the liver is a preferred organ for mRNA-based PRTs because systemically administered mRNA vehicles are predominantly trapped by the reticuloendothelial system in the liver.
“For many GARDs, the liver is a preferred organ for mRNA-based PRTs because systemically administrated mRNA vehicles are predominantly trapped by the reticuloendothelial system (RES) in the liver.”
From RNA delivery biomaterials for the treatment of genetic and rare diseases (2019) · cites this paper as [8]
The interaction between apolipoprotein E and biomaterials such as lipid and lipid derived materials facilitates accumulation in the liver.
“In addition, the interaction between apolipoprotein E (apoE) and biomaterials such as lipid and lipid derived materials facilitates the accumulation in the liver.[8, 18, 34, 39, 59, 120, 121, 124, 164, 165]”
From RNA delivery biomaterials for the treatment of genetic and rare diseases (2019) · cites this paper as [8]
Ionizable lipid and lipid derived materials acquire positive charges at low pH and become neutral at physiological pH, and have been developed for decreasing toxicity and immunogenicity while retaining delivery efficiency.
“Meanwhile, ionizable lipid and lipid derived materials, which acquire positive charges at low pH and become neutral at physiological pH, have been developed for decreasing the toxicity and immunogenicity while retaining the delivery efficiency.[8]”
From RNA delivery biomaterials for the treatment of genetic and rare diseases (2019) · cites this paper as [8]

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Lipid nanoparticles for mRNA delivery
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Self-assembled mRNA vaccines
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mRNA-based cancer therapeutics
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A Comprehensive Review of mRNA Vaccines
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Polymeric Delivery of Therapeutic Nucleic Acids
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mRNA Vaccine Era—Mechanisms, Drug Platform and Clinical Prospection
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Three decades of messenger RNA vaccine development
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Nucleic acid delivery for therapeutic applications
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Designing spatial and temporal control of vaccine responses
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Lipid-Based DNA Therapeutics: Hallmarks of Non-Viral Gene Delivery
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Lipid Nanoparticle Formulations for Enhanced Co-delivery of siRNA and mRNA
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Synthetic mRNA nanoparticle-mediated restoration of p53 tumor suppressor sensitizes p53 -deficient cancers to mTOR inhibition
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Branched‐Tail Lipid Nanoparticles Potently Deliver mRNA In Vivo due to Enhanced Ionization at Endosomal pH
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Synthetic materials at the forefront of gene delivery
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The Biomolecular Corona of Lipid Nanoparticles for Gene Therapy
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Emerging non-viral vectors for gene delivery
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Role of nanotechnology behind the success of mRNA vaccines for COVID-19
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Lipid nanoparticles for delivery of RNA therapeutics: Current status and the role of in vivo imaging
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The replacement of helper lipids with charged alternatives in lipid nanoparticles facilitates targeted mRNA delivery to the spleen and lungs
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In Vivo mRNA CAR T Cell Engineering via Targeted Ionizable Lipid Nanoparticles with Extrahepatic Tropism
Billingsley, M. M., Gong, N., Mukalel, A. J., Thatte, A. S., El-Mayta, R. D., Patel, S. K., Metzloff, A. E., Swingle, K. L., Han, X., Xue, L., et al. (2023) · Small · doi:10.1002/smll.202304378 · Cited by 286 · see citing works
Lipid Nanoparticle-Delivered Chemically Modified mRNA Restores Chloride Secretion in Cystic Fibrosis
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Lipid Nanoparticle–mRNA Formulations for Therapeutic Applications
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Lipid nanoparticles for delivery of messenger RNA to the back of the eye
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Advances in Lipid Nanoparticles for mRNA-Based Cancer Immunotherapy
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Recent advances in mRNA-LNP therapeutics: immunological and pharmacological aspects
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Lipid Nanoparticles as Delivery Systems for RNA-Based Vaccines
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Effect of mRNA-LNP components of two globally-marketed COVID-19 vaccines on efficacy and stability
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Long-term storage of lipid-like nanoparticles for mRNA delivery
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Optimization of phospholipid chemistry for improved lipid nanoparticle (LNP) delivery of messenger RNA (mRNA)
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Nanomedicines to Deliver mRNA: State of the Art and Future Perspectives
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Ionizable lipid nanoparticles encapsulating barcoded mRNA for accelerated in vivo delivery screening
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Lipid nanoparticles (LNPs) for in vivo RNA delivery and their breakthrough technology for future applications
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Dendrimer‐Based Lipid Nanoparticles Deliver Therapeutic FAH mRNA to Normalize Liver Function and Extend Survival in a Mouse Model of Hepatorenal Tyrosinemia Type I
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mRNA Delivery for Therapeutic Anti-HER2 Antibody Expression In Vivo
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Ionizable lipid nanoparticles for in utero mRNA delivery
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Adjuvant-pulsed mRNA vaccine nanoparticle for immunoprophylactic and therapeutic tumor suppression in mice
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Non-viral COVID-19 vaccine delivery systems
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Current Perspectives on “Off-The-Shelf” Allogeneic NK and CAR-NK Cell Therapies
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Nanoparticles Containing Oxidized Cholesterol Deliver mRNA to the Liver Microenvironment at Clinically Relevant Doses
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Actively targeted nanomedicines for precision cancer therapy: Concept, construction, challenges and clinical translation
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Combinatorial development of nebulized mRNA delivery formulations for the lungs
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In vivo editing of lung stem cells for durable gene correction in mice
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Functionalized lipid-like nanoparticles for in vivo mRNA delivery and base editing
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Orthogonal Design of Experiments for Optimization of Lipid Nanoparticles for mRNA Engineering of CAR T Cells
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Authors: Hajj, K. A., & Whitehead, K. A.
Affiliations: Carnegie Mellon University (US)
Corresponding author: Whitehead, Kathryn A.
ORCID: Whitehead, Kathryn A.
Venue: Nature Reviews Materials
Publisher: Springer Science and Business Media LLC
Published: 2017-09-12
Volume: 2
Issue: 10
ISSN: 2058-8437 (ISSN-L)
DOI: 10.1038/natrevmats.2017.56
OpenAlex: W2754401101
Cited by: 799
References: 166
Citations by year: 2026: 61 · 2025: 122 · 2024: 110 · 2023: 126 · 2022: 124 · 2021: 101 · 2020: 82 · 2019: 40 · 2018: 32 · 2017: 1
FWCI: 3.98
Type: journal article
Language: en
Open access: closed
Licence: www.springernature.com/gp/researchers/text-and-data-mining (tdm)
www.springernature.com/gp/researchers/text-and-data-mining (vor)
Locations: Nature Reviews Materials (publishedVersion)
Funders: Defense Advanced Research Projects Agency (D16AP00143)
Advanced Research Projects Agency
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
Physical Sciences › Materials Science › Biomaterials › Nanoparticle-Based Drug Delivery
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA and protein synthesis mechanisms
Keywords: mRNA therapeutics, mRNA delivery, synthetic materials, lipid nanoparticles, mRNA vaccines, cancer immunotherapy, in vitro transcribed mRNA

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