Cited by 499RNA Interference and Gene DeliverySARS-CoV-2 and COVID-19 ResearchImmunotherapy and Immune Responses

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The promise of mRNA vaccines: a biotech and industrial perspective

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Jackson, Nicholas A. C., Kester, Kent E., Casimiro, Danilo, Gurunathan, Sanjay, DeRosa, Frank·2020·npj Vaccines

DOI 10.1038/s41541-020-0159-8PMC PMC7000814

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Abstract

mRNA technologies have the potential to transform areas of medicine, including the prophylaxis of infectious diseases. The advantages for vaccines range from the acceleration of immunogen discovery to rapid response and multiple disease target manufacturing. A greater understanding of quality attributes that dictate translation efficiency, as well as a comprehensive appreciation of the importance of mRNA delivery, are influencing a new era of investment in development activities. The application of translational sciences and growing early-phase clinical experience continue to inform candidate vaccine selection. Here we review the state of the art for the prevention of infectious diseases by using mRNA and pertinent topics to the biotechnology and pharmaceutical industries.

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Fig. 1 Two categories of mRNA constructs are being actively evaluated. Non-replicating mRNA (NRM) constructs encode the coding sequence (CDS), and are flanked by 5′ and 3′ untranslated regions (UTRs), a 5′-cap structure and a 3′-poly-(A) tail. The self-amplifying mRNA (SAM) construct encodes additional replicase components able to direct intracellular mRNA amplification. (1) NRM and SAM are formulated in this illustration in lipid nanoparticles (LNPs) that encapsulate the mRNA constructs to protect them from degradation and promote cellular uptake. (2) Cellular uptake of the mRNA with its delivery system typically exploits membrane-derived endocytic pathways. (3) Endosomal escape allows release of the mRNA into the cytosol. (4) Cytosol-located NRM constructs are immediately translated by ribosomes to produce the protein of interest, which undergoes subsequent post-translational modification. (5) SAM constructs can also be immediately translated by ribosomes to produce the replicase machinery necessary for self-amplification of the mRNA. (6) Self-amplified mRNA constructs are translated by ribosomes to produce the protein of interest, which undergoes subsequent post-translational modification. (7) The expressed proteins of interest are generated as secreted, trans-membrane, or intracellular protein. (8) The innate and adaptive immune responses detect the protein of interest.CC BY · PubMed Central

Fig. 2 Critical quality attributes (CQAs) have been identified that dictate the performance of the mRNA construct to express the gene of interest efficiently. Five principal CQAs include 5′ capping efficiency and structure; UTR structure, length, and regulatory elements; modification of coding sequence; poly-A-tail properties; mRNA purity.CC BY · PubMed Central

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mRNA vaccines — a new era in vaccinology
Pardi, N., Hogan, M. J., Porter, F. W., & Weissman, D. (2018) · Nature Reviews Drug Discovery · doi:10.1038/nrd.2017.243 · Cited by 4,667 · cited 1×
“3 SAM differs with the inclusion of genetic replication machinery derived from positive-stranded mRNA viruses, most commonly from alphaviruses such as Sindbis and Semliki-Forest viruses.”
Background
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“First, the purity of the mRNA is a crucial determinant of yields, and it is known that the DNA-dependent RNA polymerases yield smaller oligoribonucleotide impurities as a result of abortive initiation events, 11 as well as double-stranded (ds) RNA generated by self-complementary 3′ extension, 12 which can result in ty…”
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“[41] [42] [43] [44] Much of the focus of the continued development of such LNP carrier systems involves optimization of the ionizable lipid component, with particular focus on the acid dissociation constant (pKa) and fusogenic properties (both of the ionizable component as well as helper lipid[s]), which have been dem…”
Background
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Ribose 2'-O-methylation provides a molecular signature for the distinction of self and non-self mRNA dependent on the RNA sensor Mda5
Züst, R., Cervantes-Barragan, L., Habjan, M., Maier, R., Neuman, B. W., Ziebuhr, J., Szretter, K. J., Baker, S. C., Barchet, W., Diamond, M. S., et al. (2011) · Nature Immunology · doi:10.1038/ni.1979 · Cited by 811 · cited 1×
“20 Manufacturers of mRNA vaccines pay careful attention to the choice of enzyme and reaction conditions, in order to catalyze the highest percentage of cap formation.”
Background

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The Stealth Hazard: Tungsten in Prefilled Syringes Induces mRNA Degradation and Functional Loss in Lipid Nanoparticles Despite Apparent Biophysical Stability
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Authors: Jackson, N. A. C., Kester, K. E., Casimiro, D., Gurunathan, S., & DeRosa, F.
Affiliations: Coalition for Epidemic Preparedness Innovations (US)
Sanofi (United States) (US)
Translate Bio (United States) (US)
Corresponding author: Jackson, Nicholas A. C.
ORCID: Kester, Kent E.
Gurunathan, Sanjay
Venue: npj Vaccines
Publisher: Springer Science and Business Media LLC
Published: 2020-02-04
Volume: 5
Issue: 1
Pages: 11-11
ISSN: 2059-0105 (ISSN-L)
DOI: 10.1038/s41541-020-0159-8
PMC: PMC7000814
OpenAlex: W3004539389
Cited by: 498
References: 68
Citations by year: 2026: 39 · 2025: 54 · 2024: 70 · 2023: 76 · 2022: 110 · 2021: 121 · 2020: 28
FWCI: 8.02
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0 (tdm)
creativecommons.org/licenses/by/4.0 (vor)
Locations: npj Vaccines (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Keywords: mRNA vaccines, infectious disease prevention, mRNA delivery, vaccine production, translation efficiency, vaccine development, biotechnology industry, pharmaceutical industry

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The promise of mRNA vaccines: a biotech and industrial perspective

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