Althought mRNA vaccines have been developed for nearly 30 years, but due to certain technical bottlenecks in production, stability, and reactivity, the development of mRNA vaccines has been relatively slow. During the epidemic of COVID-19, mRNA vaccine had been fully verified its effectiveness and safety for preventing infectious diseases. Here, this article summarized the key quality control attributes and related requirements of mRNA vaccine products for preventing infectious diseases by reviewing the quality control guidance documents of WHO and drug regulatory and standardization agencies, aiming to provide reference for the quality control of mRNA vaccine products for preventing infectious diseases in China.
SUN Wei, TONG Yue, YANG Ya-li, WANG Yi-ping, YANG Zhen
. Analysis of critical quality attributes about quality control of mRNA vaccines for the prevention of infectious diseases[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(5)
: 912
-915
.
DOI: 10.16155/j.0254-1793.2024.05.20
[1] WOLFF JA, MALONE RW, WILLIAMS P, et al. Direct gene transfer into mouse muscle in vivo[J]. Science, 1990, 247(4949):1465
[2] ROSS J. mRNA stability in mammalian cells [J]. Microbiol Rev,1995, 59(3):423
[3] WHO. Evaluation of the quality, safety and efficacy of RNA-based Prophylactic Vaccines for Infectious Diseases: Regulatory Considerations[EB/OL]. (2021-12-07) [2023-09-21]. https://www.who.int/publications/m/item/evaluation-of-the-quality-safety-and-efficacy-of-messenger-rna-vaccines-for-the-prevention-of-infectious-diseases-regulatory-considerations
[4] SCHMID A. Considerations for producing mrna vaccines for clinical trials [J]. Methods Mol Biol,2017,1499:237
[5] Center for Drug Evaluation. Technical Guidelines on Research and Development of Covid-19 Prophylactic mRNA Vaccines (Draft Edition) [EB/OL]. (2020-8-14) [2023-09-21]. https://www.cde. org.cn/main/news/viewInfoCommon/4cbbbe5b191c11 10c4b73bbca35b3e0c
[6] FDA. Liposomal Drug Products:Chemistry, Manufacturing, and Controls; Human Pharmacokinetic and Bioavailability; and Labeling Documentation [EB/OL]. (2018-04) [2023-09-21]. https://www.fda.gov/media/70837/download
[7] NAMIT C, DREW W,KATHRYN A, et al. mRNA vaccines for infectious diseases:principles, delivery and clinical translation[J]. Nat Rev Drug Discov,2021,20(11):817
[8] FANG E,LIU XH,LI M, et al. Advances in COVID-19 mRNA vaccine development[J]. Sig Transduct Target Ther, 2022, 7(1):94
[9] LIU T, TIAN Y, ZHENG A, et al. Design strategies for and stability of mRNA-lipid nanoparticle COVID-19 vaccines[J]. Polymers (Basel), 2022,14(19):4195
[10] ZHANG Y, SUN C, WANG C, et al. Lipids and lipid derivatives for RNA delivery[J]. Chem Rev, 2021,121(20):12181
[11] MUSAKHANIAN J, RODIER JD, DAVE M. Oxidative stability in lipid formulations:a review of the mechanisms, drivers, and inhibitors of oxidation[J]. AAPS PharmSciTech, 2022,23(5):165
[12] KUMAR V, KALONIA DS. Removal of peroxides in polyethylene glycols by vacuum drying:implications in the stability of biotech and pharmaceutical formulations[J]. AAPS PharmSciTech, 2006,7(3):E47
[13] GRIT M, CROMMELIN DJA. Chemical stability of liposomes:implications for their physical stability[J]. Chem Phys Lipids, 1993,64(1-3):3
[14] MAMONTOV E, DAEMEN LL, NOVAK E, et al. Melting and re-freezing leads to irreversible changes in the morphology and molecular-level dynamics of Pfizer-BioNTech COVID-19 Vaccine [J]. Medicina (Kaunas), 2021, 57(12):1343
[15] UDDIN MN, RONI MA. Challenges of storage and stability of mRNA-based COVID-19 vaccines[J]. Vaccines, 2021, 9(9):1033
[16] CROMMELIN D, ANCHORDOQUY T,VOLKIN T, et al. Addressing the cold reality of mRNA vaccine stability[J]. J Pharm Sci, 2021, 110(3):997
[17] SCHOENMAKER L, WITZIGMANN D, KULKARNI JA, et al. mRNA-lipid nanoparticle COVID-19 vaccines:structure and stability[J]. Int J Pharm, 2021. doi: 10.1016/.ijpharm.2021.120586
[18] USP. Analytical Procedure Life Cycle [EB/OL]. (2021-11-01) [2022-01-11]. https://online. usppf. com/usppf/document/GUID-35D7E47E-65E5-49B7-B4CC-4D96FA-230821_10101_en-US
[19] ICH. Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Q12[EB/OL]. (2019-11-20) [2022- 07-13]. https://database. ich. org/sites/default/files/Q12_Guideline_ Step4_2019_1119. pdf
[20] ICH. Validation of Analytical Procedures Q2(R2)[EB/OL]. (2022-03-24) [2022-07-13]. https://database.ich.org/sites/default/files/ICH_Q2- R2_Document_Step2_Guideline_2022_0324.pdf