Production of human FSH by recombinant engineering

• Grant number: 04/09180-2
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: April 01, 2005
• End date: July 31, 2008
• Field of knowledge: Biological Sciences - Biochemistry - Molecular Biology
• Principal Investigator: Karla de Melo Lima
• Grantee: Karla de Melo Lima
• Company: Nanocore Biotecnologia Ltda. - EPP
• City: Campinas

Abstract

The present project aims to optimize a technique for the production of follicle-stimulant hormone (FSH) obtained by recombinant technology from mammal cells, developing a process for the commercialization of the first recombinant produced in Brazil. This concerns an innovative proposal which originated in the University of São Paulo, the industrial process for which will be developed in partnership with Nanocore. The implementation of this project will be fundamental to confirm the industrial inventiveness and viability of the process, with the ultimate goal of securing the registration of their intellectual property. The intention is to optimize and outline the steps for the production and purification process of rhFSH in conditions of good manufacturing practice for use in human medicine. Among the specific objectives of the project, the following should be noted: 1) the characterization of the rhFSH producing clone; 2) the creation of a Reference Cell Bank and a Working Cell Bank as reliable and continuous sources from which the rhFSH can be consistently produced; and 3) the establishment of the culture in bioreactors, evaluating the cell growth kinetic, the consumption of substrate and the production of rhFSH and metabolites under different conditions in order to establish the most efficient process for the culturing and production of the biomedicine on a pilot scale. The production of FSH with national technology will bring a series of benefits, amongst which a reduction in the end price, which makes it possible to contemplate its early introduction into the internal market. (AU)