Preview

Drug development & registration

Advanced search

THE DEVELOPMENT OF A PRODUCTION SCALE TECHNOLOGY OF RECOMBINANT FOLLICLE STIMULATING HORMONE BIOPROCESS IN CHO CELL LINE

Abstract

The article discusses the development of a production technique for recombinant follicle-stimulating hormone used in the treatment of infertility, in the culture of Chinese hamster ovary cells. As part of the creation of the technological platform receiving hormone the bioprocess in wave-induced motion bioreactor has been optimized. A number of parameters that influence on the bioprocess was studied, as follows: optimal cell density, concentration of metabolites, temperature shift and its duration.

About the Authors

D. A. Gusarov
Research-Educational Internet Portal «ExpertBIOTECH»
Russian Federation


A. I. Gosudarev
Experimental Biotech Facilities, N.F. Gamaleya Research Center of Epydemiology and Microbiology
Russian Federation


V. D. Gusarova
Experimental Biotech Facilities, N.F. Gamaleya Research Center of Epydemiology and Microbiology
Russian Federation


D. V. Byrikhina
Experimental Biotech Facilities, N.F. Gamaleya Research Center of Epydemiology and Microbiology
Russian Federation


F. M. Izhaeva
Experimental Biotech Facilities, N.F. Gamaleya Research Center of Epydemiology and Microbiology
Russian Federation


References

1. Планирование семьи в России. URL: http://demoscope.ru/weekly/2010/0409/tema05.php#_FNR_17 (дата обращения 20.04.2016).

2. Е.К. Курбанова, Т.Ю. Чулкова, Д.В. Бырихина, А.О. Дано, В.А. Николаева, Д.А. Гусаров. Фарма-2020. Технологические аспекты производства некоторых ЖНВЛП и стратегических лекарственных средств // Биофармацевтический журнал. 2012. Т. 4(3). С. 21-45.

3. И.А. Скрылева, А.В. Исеркапов, Е.В. Воронина, Д.А. Гусаров, В.И. Швец. Разработка концепции стадии up-stream процесса получения фолликулостимулирующего гормона // Биофармацевтический журнал. 2013. Т. 5(2). С. 22-26.

4. Glycoprotein hormones alpha chain. URL: http://www.uniprot.org/uniprot/C0KRQ8. (дата обращения 20.04.2016).

5. Follitropin subunit beta. URL: http://www.uniprot.org/uniprot/P01225. (дата обращения 20.04.2016).

6. A. Ulloa-Aguirre, P. Damián-Matsumura, M. Jiménez, E. Zambrano, V. Díaz-Sánchez. Biological characterization of the isoforms of urinary human follicle-stimulating hormone contained in a purified commercial preparation // Hum Reprod. 1992. V. 7(10). P. 1371-1378.

7. K. M. Fox, J. A. Dias, P. Van Roey. Three-dimensional structure of human follicle-stimulating hormone // Molecular Endocrinology. 2001. V. 15(3). P. 378-389.

8. Human Follicle Stimulating Hormone. URL: http://www.rcsb.org/pdb/explore/explore.do?structureId=1FL7. (дата обращения 20.04.2016).

9. Д.В. Бырихина, Д.А. Гусаров, Ю.Н. Новиков. QbD в оценке биопроцесса. Применение методов анализа рисков (FMEA) в работе с одноразовыми биореакторами // Биофармацевтический журнал. 2013. Т. 5(6). С. 10-19.


Review

For citations:


Gusarov D.A., Gosudarev A.I., Gusarova V.D., Byrikhina D.V., Izhaeva F.M. THE DEVELOPMENT OF A PRODUCTION SCALE TECHNOLOGY OF RECOMBINANT FOLLICLE STIMULATING HORMONE BIOPROCESS IN CHO CELL LINE. Drug development & registration. 2016;(2):80-84. (In Russ.)

Views: 1205


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)