Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens
Open accessAbstract
The preferred product characteristics (for chemistry, control, and manufacture), in addition to safety and efficacy, are quintessential requirements for any successful therapeutic. Messenger RNA vaccines constitute a relatively new alternative to traditional vaccine development platforms, and thus there is less clarity regarding the criteria needed to ensure regulatory compliance and acceptance. Generally, to identify the ideal product characteristics, a series of assays needs to be developed, qualified and ultimately validated to determine the integrity, purity, stability, and reproducibility of a vaccine target. Here, using the available literature, we provide a summary of the array of biophysical and biochemical assays currently used in the field to characterize mRNA vaccine antigen candidates. Moreover, we review various in vitro functional cell-based assays that have been employed to facilitate the early assessment of the biological activity of these molecules, including the predictive immune response triggered in the host cell. Messenger RNA vaccines can be produced rapidly and at large scale, and thus will particularly benefit from well-defined and well-characterized assays ultimately to be used for in-process, release and stability-indications, which will allow equally rapid screening of immunogenicity, efficacy, and safety without the need to conduct often lengthy and costly in vivo experiments.
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Quality control of COVID-19 mRNA vaccines focuses on raw materials (plasmids, biobanks, lipids, nucleotides, and enzymes used in the production process), semi-finished, and final product.
“Quality control of COVID-19 mRNA vaccines focuses on raw materials (plasmids, biobanks, lipids, nucleotides, and enzymes used in the production process), semi-finished, and final product.445,465”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [465]
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- Authors
- Poveda, C., Biter, A. B., Bottazzi, M. E., & Strych, U.
- Affiliations
- Baylor College of Medicine (US)
- Texas Children’s Hospital Center for Vaccine Development, Baylor College of Medicine, 1102 Bates Street, Houston, TX 77030, USA
- Corresponding author
- Strych, Ulrich
- Venue
- Vaccines
- Publisher
- MDPI AG
- Published
- 2019-09-27
- Volume
- 7
- Issue
- 4
- Pages
- 131
- ISSN
- 2076-393X (ISSN-L)
- PMC
- PMC6963847
- OpenAlex
- W2976917752
- Cited by
- 54
- References
- 83
- Citations by year
- 2026: 2 · 2025: 10 · 2024: 10 · 2023: 9 · 2022: 11 · 2021: 9 · 2020: 2 · 2019: 1
- FWCI
- 0.51
- Type
- journal article
- Language
- en
- Open access
- gold
- dx.doi.org
- Licence
- Locations
- Vaccines (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Robert J. and Helen C. Kleberg Foundation (n/a)
- Texas Children’s Hospital (n/a)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Keywords
- mRNA vaccines, product characterization, assay validation, mRNA stability, purity, reproducibility, cell-based functional assay, immune response, regulatory compliance, stability-indicating assay
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