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Published on: June 10, 2022
mRNA Therapeutic Modalities Design, Formulation and Manufacturing under Pharma 4.0 Principles
Andreas Ouranidis1,2, Theofanis Vavilis3, Evdokia Mandala4
1Department of Pharmaceutical Technology, School of Pharmacy, Aristotle University of Thessaloniki, 54124 Thessaloniki, Greece.
Messenger RNA (mRNA) therapeutics offer rapid production and versatile applications beyond vaccines. This work reviews mRNA production, modifications, delivery, and stability to address manufacturing challenges.
Area of Science:
- Biotechnology
- Molecular Biology
- Pharmaceutical Sciences
Background:
- Messenger RNA (mRNA) therapeutics have emerged as a significant advancement, particularly for vaccine development against SARS-CoV-2.
- mRNA technology offers advantages such as rapid design-to-production cycles, production line flexibility, enhanced safety profiles compared to DNA therapeutics, and precise control over translated peptides.
Purpose of the Study:
- To review the current state of laboratory and scaled production of mRNA therapeutics.
- To explore modifications enhancing mRNA efficacy and reducing immunogenicity.
- To discuss available delivery vectors and stability considerations for long-term storage.
Main Methods:
- Review of scientific literature on mRNA production, modification, delivery, and stability.
- Analysis of challenges in industrial-scale mRNA manufacturing.
- Examination of emerging technologies like Manufacturing 4.0 for continuous mRNA production.
Main Results:
- Global demand for mRNA has exposed limitations in industrial production, formulation, efficacy, and applicability.
- Continuous, smart Manufacturing 4.0 technologies are proposed to overcome these challenges.
- Various mRNA modifications, delivery vectors, and stability strategies are being investigated.
Conclusions:
- mRNA therapeutics present a versatile platform with broad clinical potential.
- Addressing manufacturing, formulation, and stability challenges is crucial for wider adoption.
- Advancements in mRNA technology are essential for future therapeutic applications.
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