Design of Composition of Active Pharmaceutical Ingredients based on E7-HSP70 Hybrid Recombinant Proteins

Автор: M.A. Zhuchenko, N.A. Gavrilova, S.A. Cherepushkin, A.A. Klishin, and A.E. Kukharenko

Страница: 38-48

Design of Composition of Active Pharmaceutical Ingredients based on E7-HSP70 Hybrid Recombinant Proteins

Biotekhnologiya, 2015, N 1, P. 38-48

UDC 573.6.086.83:577.21:[615.373.3+615.277]

Section:  “Biologicals Technology”

M.A. Zhuchenko ^*,  N.A. Gavrilova,  S.A. Cherepushkin,  A.A. Klishin,  and  A.E. Kukharenko

The Stale Research Institute for Genetics and Selection of Industrial Microorganisms,  117545, Moscow Russia

e-mail:  axiflipper@gmail.com

The approaches to the stabilization of the recombinant fusion oncoproteins E7 16 and 18 conjugated with heat shock protein 70 in solutions have been studied. The screening of pharmaceutical active substances was carried out by the accelerated storage test at elevated temperatures. The first stage of the study was aimed at determining of the pH range providing the best stability of the physicochemical quality parameters of the proteins which turned to be 6.8—7.4. The second and third steps were aimed at identification of excipients that make the greatest contribution to the increased storage stability of proteins in solution showed that sucrose and polysorbate 80 constitute the most stable composition. The temperature –20 °C allows to keep the quality parameters on a desired level for at least 12 months.

Key words:  accelerated storage test,  active pharmaceutical ingredient,  human papilloma virus,  screening,  stability.

29.05.2015, 1493 просмотра.