Steps and challenges in the implementation of a plasma fractionation program: Brazil experience

Abstract

In the year 2005, Brazil has decided to create a state-owned company for fractionating the country’s plasma, and a society named Hemobras was put in place. The project took into account the plasma availability, local regulatory capability and the existence of an internal market for plasma derivatives. Transfer of technology process was initiated, with a foreign plasma fractionator, and a plasma toll fractionation was associated to the tech transfer, in order to accelerate, step by step, the technology incorporation. The main challenges regarding the project were related to engineering aspects, including elaboration of basic and detailed designs, since the country had little local expertise in this field. A mixed approach was used, consisting on hiring a specialized body of engineers as well as outsourcing national and international engineer companies. Manpower recruitment was another difficulty, because there were very few specialists in the manufacture of biological medicines and plasma fractionation. Hemobras has adopted a heavy training program to circumvent this issue. Finally, Hemobras developed a massive investment focused on improving plasma quality in a joint program with blood centers. This program was able to greatly increase the plasma availability in Brazil. Overall, installing a plasma fractionation facility is a very complex and expensive task, with many challenges to be carefully addressed.