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Review

Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens

by 1,2,†, 1,2,†, 2,3,4 and 1,2,*
1
Department of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, One Baylor Plaza, BCM113 Houston, TX 77030, USA
2
Texas Children’s Hospital Center for Vaccine Development, Baylor College of Medicine, 1102 Bates Street, Houston, TX 77030, USA
3
Department of Pediatrics and Molecular Virology & Microbiology, National School of Tropical Medicine, Baylor College of Medicine, One Baylor Plaza, BCM113 Houston, TX 77030, USA
4
Department of Biology, College of Arts and Sciences, Baylor University, Waco, TX 76798, USA
*
Author to whom correspondence should be addressed.
Both authors contributed equally to this review.
Vaccines 2019, 7(4), 131; https://doi.org/10.3390/vaccines7040131
Received: 29 August 2019 / Revised: 17 September 2019 / Accepted: 23 September 2019 / Published: 27 September 2019
(This article belongs to the Special Issue RNA Vaccines)
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. View Full-Text
Keywords: product characteristics; capping; dendritic cells; antigen presenting cells; therapeutics product characteristics; capping; dendritic cells; antigen presenting cells; therapeutics
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MDPI and ACS Style

Poveda, C.; Biter, A.B.; Bottazzi, M.E.; Strych, U. Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens. Vaccines 2019, 7, 131. https://doi.org/10.3390/vaccines7040131

AMA Style

Poveda C, Biter AB, Bottazzi ME, Strych U. Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens. Vaccines. 2019; 7(4):131. https://doi.org/10.3390/vaccines7040131

Chicago/Turabian Style

Poveda, Cristina, Amadeo B. Biter, Maria E. Bottazzi, and Ulrich Strych. 2019. "Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens" Vaccines 7, no. 4: 131. https://doi.org/10.3390/vaccines7040131

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