[Modern methods for the manufacture of therapeutic coagulation factors]

In a modern therapy concept coagulation factor concentrates are widely used for prophylaxis of bleeding events and in intensive care medicine. In the past their use was limited by the risk of transmitting virus diseases to the patient. Therefore, it was a challenge to modern plasma fractionation to develop purification processes which are able to eliminate and inactivate viruses. At present several methods for virus inactivation are used; their efficiency is not finally proven. Practical experience exists with a method in which viruses are inactivated by heat treatment in solution. A similar process is used since more than 40 years to produce albumin and was proven to be safe. Today, all coagulation factor preparations can be treated by this inactivation method and produced in large scale. Together with a high degree of viruses elimination during the purification process the therapy with coagulation factors has become much safer.