mRNA Therapeutic Modalities Design, Formulation and Manufacturing under Pharma 4.0 Principles
Abstract
:1. Introduction
2. Basic Features of Moderna mRNA-1273 and Pfizer-BioNTech BNT162b2 COVID-19 mRNA Vaccines
3. mRNA Preparation Process
3.1. Plasmid Linearization
3.2. In-Vitro mRNA Transcription
3.3. mRNA Purification
3.4. mRNA Encapsulation
4. Analytical Approaches
4.1. For mRNA
4.2. For the LPNs of mRNA
4.3. For DNA Plasmid Purification
4.4. For DNA Analysis
5. Differences between Laboratory and Industrial Scale
6. Formulation Strategies
6.1. Viral Vectors
6.2. Non-Viral Vectors
6.2.1. Polymer-Based Vectors
6.2.2. Lipid Based Vectors
6.2.3. Polymer-Lipid Hybrid Vectors
6.2.4. Other Vectors
7. mRNA Stability and Modifications
7.1. Structural Modifications
7.1.1. 5′ Cap
7.1.2. 5′ and 3′ UTRs
7.1.3. Open Reading Frame
7.1.4. Poly(A) Tail
8. Storage Considerations
9. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Ouranidis, A.; Vavilis, T.; Mandala, E.; Davidopoulou, C.; Stamoula, E.; Markopoulou, C.K.; Karagianni, A.; Kachrimanis, K. mRNA Therapeutic Modalities Design, Formulation and Manufacturing under Pharma 4.0 Principles. Biomedicines 2022, 10, 50. https://doi.org/10.3390/biomedicines10010050
Ouranidis A, Vavilis T, Mandala E, Davidopoulou C, Stamoula E, Markopoulou CK, Karagianni A, Kachrimanis K. mRNA Therapeutic Modalities Design, Formulation and Manufacturing under Pharma 4.0 Principles. Biomedicines. 2022; 10(1):50. https://doi.org/10.3390/biomedicines10010050
Chicago/Turabian StyleOuranidis, Andreas, Theofanis Vavilis, Evdokia Mandala, Christina Davidopoulou, Eleni Stamoula, Catherine K. Markopoulou, Anna Karagianni, and Kyriakos Kachrimanis. 2022. "mRNA Therapeutic Modalities Design, Formulation and Manufacturing under Pharma 4.0 Principles" Biomedicines 10, no. 1: 50. https://doi.org/10.3390/biomedicines10010050