Toward QbD Process Understanding on DNA Vaccine Purification Using Design of Experiment.

ABSTRACT: DNA vaccines, the third generation of vaccines, are a promising therapeutic option for many diseases as they offer the customization of their ability on protection and treatment with high stability. The production of DNA vaccines is considered rapid and less complicated compared to others such as mRNA vaccines, viral vaccines, or subunit protein vaccines. However, the main issue for DNA vaccines is how to produce the active DNA, a supercoiled isoform, to comply with the regulations. Our work therefore focuses on gaining a process understanding of the purification step which processes parameters that have impacts on the critical quality attribute (CQA), supercoiled DNA and performance attribute (PA), and step yield. Herein, pVax1/lacZ was used as a model. The process parameters of interest

SUBMITTER: Hocharoen L 

PROVIDER: S-EPMC8153680 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature