Research Advances on the Stability of mRNA Vaccines

Cheng, Feiran; Wang, Yiping; Bai, Yu; Liang, Zhenglun; Mao, Qunying; Liu, Dong; Wu, Desheng Dash; Xu, Miao

doi:10.3390/v15030668

Cited by 48 publications

(20 citation statements)

References 100 publications

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“…In the elevated conditions, the LNPs were supposed to have accelerated degradation. It is commonly acknowledged in the industry that mRNA integrity is a critical attribute to monitoring mRNA vaccines’ functionality and stability [ 24 , 25 ]. Our data show that potency decreases with decreasing intact mRNA linearly until there is a sudden drop in potency at ~60% intact.…”

Section: Discussionmentioning

confidence: 99%

Correlating Stability-Indicating Biochemical and Biophysical Characteristics with In Vitro Cell Potency in mRNA LNP Vaccine

Tong,

Raffaele,

Feller

et al. 2024

Vaccines

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The development of mRNA vaccines has increased rapidly since the COVID-19 pandemic. As one of the critical attributes, understanding mRNA lipid nanoparticle (LNP) stability is critical in the vaccine product development. However, the correlation between LNPs’ physiochemical characteristics and their potency still remains unclear. The lack of regulatory guidance on the specifications for mRNA LNPs is also partially due to this underexplored relationship. In this study, we performed a three-month stability study of heat-stressed mRNA LNP samples. The mRNA LNP samples were analyzed for their mRNA degradation, LNP particle sizes, and mRNA encapsulation efficiency. In vitro cell potency was also evaluated and correlated with these above-mentioned physiochemical characterizations. The mRNA degradation–cell potency correlation data showed two distinct regions, indicating a critical cut-off size limit for mRNA degradation. The same temperature dependence was also observed in the LNP size–cell potency correlation.

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Section: Discussionmentioning

confidence: 99%

Correlating Stability-Indicating Biochemical and Biophysical Characteristics with In Vitro Cell Potency in mRNA LNP Vaccine

Tong,

Raffaele,

Feller

et al. 2024

Vaccines

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“…Retaining mRNA integrity, altering mRNA fragment length, optimizing mRNA sequence, modifying mRNA, and using circRNA are found to be useful in increasing the shelf life of the vaccine. In addition, suitable excipients, appropriate lipid nanoparticle (LNP) delivery systems, and following strict manufacturing conditions such as pH/temperature maintenance and lyophilization are also crucial to maintain vaccine stability ( 104 ).…”

Section: Vaccinationmentioning

confidence: 99%

Novel antioxidant protein target therapy to counter the prevalence and severity of SARS-CoV-2

Kaur,

Dey,

Rawat

et al. 2024

Front. Immunol.

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BackgroundThis review analyzed the magnitude of the COVID-19 pandemic globally and in India and the measures to counter its effect using natural and innate immune booster molecules. The study focuses on two phases: the first focuses on the magnitude, and the second on the effect of antioxidants (natural compounds) on SARS-CoV-2.MethodsThe magnitude of the prevalence, mortality, and comorbidities was acquired from the World Health Organization (WHO) report, media, a report from the Ministry of Health and Family Welfare (MoHFW), newspapers, and the National Centre of Disease Control (NCDC). Research articles from PubMed as well as other sites/journals and databases were accessed to gather literature on the effect of antioxidants.ResultsIn the elderly and any chronic diseases, the declined level of antioxidant molecules enhanced the reactive oxygen species, which in turn deprived the immune system.ConclusionInnate antioxidant proteins like sirtuin and sestrin play a vital role in enhancing immunity. Herbal products and holistic approaches can also be alternative solutions for everyday life to boost the immune system by improving the redox balance in COVID-19 attack. This review analyzed the counteractive effect of alternative therapy to boost the immune system against the magnitude of the COVID-19 pandemic.

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“…Furthermore, with respect to delivery systems, they can be delineated into viral vectors and nonviral vectors. Among them, RNA therapeutic products, due to their specificity and safety (nonintegration), have gained significant attention and developed a variety of RNA drugs, including small interfering RNA (siRNA), , antisense oligonucleotides (ASO), , microRNA (miRNA), , mRNA (mRNA), − self-amplifying RNA (saRNA), , etc. Whereas DNA therapy has comparatively gradual advancement, it offers undeniable advantages such as safety, no volume limitations, flexible delivery methods, simple production process, and wide applicability.…”

Section: Introductionmentioning

confidence: 99%

DNA-Based Nonviral Gene Therapy─Challenging but Promising

Guan,

Pei,

Song

2024

Mol. Pharmaceutics

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Over the past decades, significant progress has been made in utilizing nucleic acids, including DNA and RNA molecules, for therapeutic purposes. For DNA molecules, although various DNA delivery systems have been established, viral vector systems are the go-to choice for large-scale commercial applications. However, viral systems have certain disadvantages such as immune response, limited payload capacity, insertional mutagenesis and pre-existing immunity. In contrast, nonviral systems are less immunogenic, not size limited, safer, and easier for manufacturing compared with viral systems. What's more, nonviral DNA vectors have demonstrated their capacity to mediate specific protein expression in vivo for diverse therapeutic objectives containing a wide range of diseases such as cancer, rare diseases, neurodegenerative diseases, and infectious diseases, yielding promising therapeutic outcomes. However, exogenous plasmid DNA is prone to degrade and has poor immunogenicity in vivo. Thus, various strategies have been developed: (i) designing novel plasmids with special structures, (ii) optimizing plasmid sequences for higher expression, and (iii) developing more efficient nonviral DNA delivery systems. Based on these strategies, many interesting clinical results have been reported. This Review discusses the development of DNA-based nonviral gene therapy, including novel plasmids, nonviral delivery systems, clinical advances, and prospects. These developments hold great potential for enhancing the efficacy and safety of nonviral gene therapy and expanding its applications in the treatment of various diseases.

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Research Advances on the Stability of mRNA Vaccines

Cited by 48 publications

References 100 publications

Correlating Stability-Indicating Biochemical and Biophysical Characteristics with In Vitro Cell Potency in mRNA LNP Vaccine

Correlating Stability-Indicating Biochemical and Biophysical Characteristics with In Vitro Cell Potency in mRNA LNP Vaccine

Novel antioxidant protein target therapy to counter the prevalence and severity of SARS-CoV-2

DNA-Based Nonviral Gene Therapy─Challenging but Promising

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