Development of Technology for Production of Recombinant Human Erythropoetin Freeze-dried Substance

Автор: I.F. Radaeva, M.E. Kolesova, V.S. Serebrova, N.A. Varaksin, T.G. Ryabicheva, N.V. Zhilina, and E.A. Nechaeva

Страница: 67-73

Development of Technology for Production of Recombinant Human Erythropoetin Freeze-dried Substance

Biotekhnologiya, 2013, N 2, P. 67-73

UDC 57.085.23

Section:  “Biologicals Technology”

I.F. Radaeva ^*,  M.E. Kolesova,  V.S. Serebrova,  N.A. Varaksin,  T.G. Ryabicheva,  N.V. Zhilina,  and  E.A. Nechaeva

The State Research Center of Virology and Biotechnology Vector (SRC VB Vector),  630559, Kol'tsovo, Novosibirskaya oblast Russia

e-mail:  radaeva@vector.nsc.ru

On the basis of CHOpE cell culture, a technology for the production of freeze-dried substance of recombinant human erythropoetin (rhEPO) with a set activity dedicated to peroral and external application has been developed. It includes the following stages: cell culturing, collection of EPO-containing culture liquid, concentration, purification by filtration and freeze-drying. The molecular mass the obtained of rhEPO was equal to 32—37,5 kD according to electrophoresis. The  substance  of  rhEPO comprises a homogeneous porous hygroscopic yellow mass soluble in distilled water; pH of the 1% solution was 6.5—7.4. Testing of rhEPO on animals failed to detect any signs of toxicity. The peroral introduction of the obtained tabletted substance in mice induced a reliable 1,8—2-fold increase in the number of rethiculocytes in peripheral blood. Fungi, aerobic bacteria, bacteria of the Enterobacteriaceae family, Staphylococcus aureus and Pseudomonas aeruginosa were not detected in the preparation. The resulting substance can be suitable for the use in the manufacturing of rhEPO-containing final pharmaceuticals including tablet forms.

Key words:  СНОрЕ cell culture,  pharmaceuticals substance,  recombinant human erythropoetin.

The full English version of the article was published in “Biotechnology in Russia”, 2013, Issue 2, pp. 67-73 as I.F. Radaeva, M.E. Kolesova, V.S. Serebrova, N.A. Varaksin, T.G. Ryabicheva, N.V. Zhilina, and E.A. Nechaeva “Development of Technology for Production of Recombinant Human Erythropoetin Freeze-dried Substance”.

It is contained at the Russian Scientific Electron Library website:  http://elibrary.ru/item.asp?id=21818760

10.04.2015, 1654 просмотра.