Research Progress on Plasmid DNA Production Process and Quality Control

Jiaming Chen

doi:10.54097/x4m92503

Authors

Jiaming Chen

DOI:

https://doi.org/10.54097/x4m92503

Keywords:

Plasmid DNA, Production process, Gene therapy, mRNA vaccine.

Abstract

Plasmid DNA, as the core material of the new generation of nucleic acid vaccines, has broad market potential, especially playing a critical role in gene therapy and mRNA vaccine development. With the rapid development of biotechnology, the production process and quality control techniques of plasmid DNA are continuously innovated and optimized. This paper reviews key technological advances in plasmid DNA production, including strategies for increasing plasmid yield, post-fermentation processing, impurity removal methods, and the purification process for high-purity supercoiled plasmid DNA. In addition, the quality control system of plasmid DNA production is discussed in detail. The plasmid DNA production process encompasses multiple steps, including fermentation, extraction, purification, and concentration, where optimization and innovation at each stage significantly contribute to enhancing production efficiency and product quality. Regarding quality control, key indicators such as purity, endotoxin absence, sequence integrity, and concentration are strictly monitored to ensure the safety and effectiveness of plasmid DNA. Simultaneously, the application of automated production and antibiotic-free selection marker systems has brought new technological breakthroughs to plasmid production. In the future, as global quality control standards are gradually unified, the application prospects of plasmid DNA in vaccine development, gene therapy, and personalized medicine will become more promising. By continuously optimizing production processes, reducing costs, and improving quality control standards, plasmid DNA will continue to play an essential role in the biopharmaceutical field, driving further advancement of related technologies.

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