[Pilot-scale production and quality control of multiepitope hepatitis B virus DNA vaccine].
OBJECTIVE
To establish a method for pilot-scale production and quality control of multiepitope hepatitis B virus (HBV) DNA vaccine (PVAX-HS).


METHODS
Recombinant DH5alpha/pVAX-HS was obtained by fed-batch fermentation, and the plasmid was extracted by alkaline lysis and concentrated by ultrafiltration. The plasmid DNA was purified by a three-step column chromatography to obtain the DNA vaccine, and quality control tests were performed on the final product.


RESULTS
The quantity of the fed-batch product reached 50-60 g/L, and the final plasmid output was 1.0 mg per gram of the bacteria. The quality of the DNA vaccine met the requirements for medical use.


CONCLUSIONS
A simple and stable procedure was established for pilot-scale production of multiepitope HBV DNA vaccine, which allows potential large-scale production of the DNA vaccine.
Guo
Yan
Y
National Hepatobiliary and Enteric Surgery Research Center of Ministry of Health, Central South University, Changsha, 410078, China. yanguo615@163.com
Hui
Chang-ye
CY
D000939:Epitopes / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000096:biosynthesis* / Q000235:genetics / Q000276:immunology; D010865:Pilot Projects; D011786:Quality Control; D019444:Vaccines, DNA / Q000096:biosynthesis* / Q000235:genetics / Q000276:immunology
D000939:Epitopes; D017325:Hepatitis B Vaccines; D019444:Vaccines, DNA