Large scale production of a vaccine component using genetically modified Escherichia coli

COGEM has been asked to advice on possible risks for the environment of the large scale production of a vaccincomponent using Escherichia coli. The vaccine is directed against progressive atrophic rhinitis in pigs. The vaccincomponent (detoxified dermonecrotic toxin of Pasteurella multocida) had no toxic properties. Beside this, the E.coli K12 strain, in which the DNA-fragment is inserted, is biologically contained and can therefore not survive outside laboratory conditions. The vaccine is produced in fermentors with a maximum volume of 3000 liters. The vaccincomponent is isolated from the broth in several steps. The waste is collected in a kill tank and heated for 15 minutes at 80 ºC to inactivate remaining E. coli cells. COGEM is of the opinion that the inactivation method is proper to inactivate living cells. Considering the above-mentioned, in COGEM’s opinion, the proposed activities pose a negligible risk for human health and the environment when carried out under physical contained (MI-II) conditions.