The Institute of Drug Technology (Farmanguinhos/Fiocruz) is to have technology transferred from the Ukrainian laboratory Indar S.A for the production of the Recombinant Human Insulin in Brazil.  Fiotec supports the consolidation of strategic efforts for setting this new technology incorporation model, by sublicensing the bottling activities. By the end of the process, Farmanguinhos will be qualified to produce insulin crystals and the recombinant insulin drug.

The government’s commitment to internalize the technology was remarked by the signature of technical and scientific agreement in July 2006, including five stages for the transfer to be concluded. Farmanguinhos Bioproducts Laboratory received early in this month representatives from Indar for a training, part of the third and fourth stages of the process. In addition to the training, they have also seen the analytical methodologies processes, included in the technology transfer.

Otavio Padulan, responsible for the Bioproducts Laboratory, explained in an interview to the unit website that “the technology is based on the fermentation process, by using genetically modified bacterial strains, the insulin makers”. Bárbara Ferreira, head of the Biotechnology Division (DBTEC), added that the laboratorial scale absorption phase has to be finished by March 2016, for the pilot technology, which will be of up to 450 liters, to be absorbed, and, after that, the factory stage to start.

Drug supply
The agreement is also including the import of the end product, together with the technology transfer. Therefore, since November 2007, Farmanguinhos is purchasing 500,000 bottles per month, a quantity enough to cover the distribution of the drug in the states of Espírito Santo, Pernambuco, Minas Gerais, Rio Grande do Sul, Rio de Janeiro and Bahia, under the plan set by the Ministry of Health.

The recombinant human insulin is made with biosynthesis by the recombinant DNA technology process and the suspension appears cloudy and white. The drug has easy glucose uptake while prevents the liver from producing sugar.

According to the International Diabetes Federation, more than 11.6 million people are with diabetes in Brazil. By bringing the insulin production to the country, Farmanguinhos will be able to service the market and have technologic autonomy, getting rid of the drug supply difficulties and the vulnerability to the prices variation in the world market.

*With information from Farmanguinhos website, Fiocruz News Agency and Ministry of Health