Producing Plasmid DNA Template for Clinical Grade RNA Vaccine Manufacture

Overview

Journal Methods Mol Biol

Specialty Molecular Biology

Date 2024 May 30

PMID 38814401

Authors

Ram Shankar

Marco Schmeer

Martin Schleef

Affiliations

Soon will be listed here.

Abstract

A plasmid production process has been established to manufacture plasmid DNA at a large scale in High-Quality grade. This is used as a starting material to produce mRNA vaccines for clinical trials. Recently, the World Health Organization (WHO) has released regulatory guidelines related to the quality, safety, and efficacy for DNA- as well as for mRNA-based vaccines. Following an extraordinary year of scientific, regulatory, and manufacturing developments, the scientific community today stands considerably better equipped to deal with urgent production requirements in large scale for nucleic acid-based vaccinations and therapies. Going forward, work needs to be done in better coordinating the supply and logistics of essential raw materials for biological manufacturing, especially under emergency conditions.

References

Voysey M, Clemens S, Madhi S, Weckx L, Folegatti P, Aley P . Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2020; 397(10269):99-111. PMC: 7723445. DOI: 10.1016/S0140-6736(20)32661-1. View

Vasileiou E, Simpson C, Shi T, Kerr S, Agrawal U, Akbari A . Interim findings from first-dose mass COVID-19 vaccination roll-out and COVID-19 hospital admissions in Scotland: a national prospective cohort study. Lancet. 2021; 397(10285):1646-1657. PMC: 8064669. DOI: 10.1016/S0140-6736(21)00677-2. View

Cova L . DNA vaccine: a promising new approach for chronic hepatitis B therapy. Future Virol. 2011; 2(5):421-424. PMC: 3184607. DOI: 10.2217/17460794.2.5.421. View

Tombacz I, Weissman D, Pardi N . Vaccination with Messenger RNA: A Promising Alternative to DNA Vaccination. Methods Mol Biol. 2020; 2197:13-31. DOI: 10.1007/978-1-0716-0872-2_2. View

Beasley D . New international guidance on quality, safety and efficacy of DNA vaccines. NPJ Vaccines. 2020; 5(1):53. PMC: 7303182. DOI: 10.1038/s41541-020-0199-0. View