Generic interferon-beta

Multiple sclerosis (MS) is the most common disease of the central nervous system. Estimates put the number of people suffering from multiple sclerosis at about 2.5 million worldwide. The only therapeutic successes achieved so far have been with interferon-beta, a protein produced naturally in the body. It slows down the progression of the illness and reduces the relapse rate. Biotechnological techniques make it possible to engineer this endogenous protein in bacterial or mammalian cells. An interferon-beta-1a, whose biotechnical engineering and production up to the pilot scale was optimized at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB in collaboration with CinnaGen Company, has 2006 been approved as biogeneric by the Iranian Food and Drug Administration (IFDA). It is produced and marketed in Iran as CinnoVex by the biotech company CinnaGen.

IGB's project group "Genetic Engineering" under Professor Bernd Otto in Hannover, Germany, successfully cloned the human protein into a suitable expression vector and established the production of the natural protein by a stable transfection in a mammalian cell line. The interferon-beta-1a hereby obtained is glycosylated like the human protein. In vitro it shows a higher biological activity than interferon-beta-1b, which is produced in bacteria and is not glycosylated.

In the Fraunhofer IGB Stuttgart laboratories a multi-disciplinary team developed the production of the pharmaceutical protein up to pilot scale. We have developed the fermentation process as well as the downstream processing, resulting in a highly purified protein. We identified the protein by amino acid sequencing and proved its antiviral effects. The Iranian CinnaGen gave proof of its clinical effectiveness within three years, including appropriate quality control and clinical trials.