Producing Plasmid DNA Template for Clinical Grade RNA Vaccine Manufacture.
Methods Mol Biol
; 2786: 303-319, 2024.
Article
em En
| MEDLINE
| ID: mdl-38814401
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Plasmídeos
/
Vacinas de DNA
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article