Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens
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 t...
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doaj-c5070be95726494daa5c90c5b05ec7432020-11-25T01:48:11ZengMDPI AGVaccines2076-393X2019-09-017413110.3390/vaccines7040131vaccines7040131Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine AntigensCristina Poveda0Amadeo B. Biter1Maria Elena Bottazzi2Ulrich Strych3Department of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, One Baylor Plaza, BCM113 Houston, TX 77030, USADepartment of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, One Baylor Plaza, BCM113 Houston, TX 77030, USATexas Children’s Hospital Center for Vaccine Development, Baylor College of Medicine, 1102 Bates Street, Houston, TX 77030, USADepartment of Pediatrics, National School of Tropical Medicine, Baylor College of Medicine, One Baylor Plaza, BCM113 Houston, TX 77030, USAThe 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.https://www.mdpi.com/2076-393X/7/4/131product characteristicscappingdendritic cellsantigen presenting cellstherapeutics |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Cristina Poveda Amadeo B. Biter Maria Elena Bottazzi Ulrich Strych |
spellingShingle |
Cristina Poveda Amadeo B. Biter Maria Elena Bottazzi Ulrich Strych Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens Vaccines product characteristics capping dendritic cells antigen presenting cells therapeutics |
author_facet |
Cristina Poveda Amadeo B. Biter Maria Elena Bottazzi Ulrich Strych |
author_sort |
Cristina Poveda |
title |
Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens |
title_short |
Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens |
title_full |
Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens |
title_fullStr |
Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens |
title_full_unstemmed |
Establishing Preferred Product Characterization for the Evaluation of RNA Vaccine Antigens |
title_sort |
establishing preferred product characterization for the evaluation of rna vaccine antigens |
publisher |
MDPI AG |
series |
Vaccines |
issn |
2076-393X |
publishDate |
2019-09-01 |
description |
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. |
topic |
product characteristics capping dendritic cells antigen presenting cells therapeutics |
url |
https://www.mdpi.com/2076-393X/7/4/131 |
work_keys_str_mv |
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