Total number
Full text
Total number
Full text
Number of local repositories
Full text
0216U003077,
0114U006497
,
Development of regulations for the work with E. coli strain - producer of Erysipelothrix rhusiopathiae SpaA (tr) recombinant protein
Golovko A.N.,
13-01-2016
State research-control institute of biotechnology and strains of microorganisms
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".
Бабкін М.В.
Виговська Л.М.
Дерябін О.М.
Кацимон В.В.
Пінчук Н.Г.
2020-04-02
Updated: 2025-12-08
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