[Pilot-scale production and quality control of multiepitope hepatitis B virus DNA vaccine]

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

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.

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.

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.