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Information × Registration Number 0216U003077, 0114U006497 , R & D reports Title Development of regulations for the work with E. coli strain - producer of Erysipelothrix rhusiopathiae SpaA (tr) recombinant protein popup.stage_title Head Golovko A.N., Registration Date 13-01-2016 Organization State research-control institute of biotechnology and strains of microorganisms popup.description2 This technology sets the rules of procedure and test the stability of the parent bank culture E. coli BL21 (DE3) / pETSPAA (tr) (hereinafter PBC) - producer of recombinant protein SpaA bacteria Erysipelothrix rhusiopathiae. To prevent contamination of PBC and its master seed outsider microbial growth media, additives, utensils and other materials during cooking PBC direct contact with the producer cells must be sterile. To prevent contamination of PBC and its microorganisms outsider master seed all procedures that provide open access to the producer must be conducted in laminar box that is at least in the area and can provide box in the work area clean air zone A. To prevent contact with the operator of the producer and the operator and the environment from producers, laminar box, which is designed for manipulation with public producers, must meet the class II biosafety. The results obtained during tests PBC apply to the entire volume of PBC and are valid until the next trial. Test PBC should be in accordance with guidelines European Medicines Agency ICH Topic Q 5 D "Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological / Biological Products". Product Description popup.authors Бабкін М.В. Виговська Л.М. Дерябін О.М. Кацимон В.В. Пінчук Н.Г. popup.nrat_date 2020-04-02 Close