title: [Pilot-scale production and quality control of multiepitope hepatitis B virus DNA vaccine].
abstract: 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.
authors.affiliation: National Hepatobiliary and Enteric Surgery Research Center of Ministry of Health, Central South University, Changsha, 410078, China. yanguo615@163.com
authors.forename: Yan
authors.initials: Y
authors.lastname: Guo
authors.forename: Chang-ye
authors.initials: CY
authors.lastname: Hui
mesh_terms: 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
chemical_list: D000939:Epitopes; D017325:Hepatitis B Vaccines; D019444:Vaccines, DNA