Pathogen Inactivated Plasma.

Descriptions

SNBTS requires a pathogen inactivated frozen plasma product for use in plasma exchange procedures, such as in the treatment of TTP (Thrombotic Thrombocytopenic Purpura) in hospitals across Scotland. The product should also be suitable for use in massive transfusion and to replace multiple clotting factors.The product should contain clinically useful clotting factors and in particular must contain ADAMTS13 to a similar level to that found in Fresh Frozen Plasma (FFP). The characteristics of this product should therefore be similar to that of FFP.The provision of this product for use in such treatments is recommended as a measure to reduce the risk of vCJD transmission in patients who would otherwise be exposed to a large number of UK blood donors over the course of their treatment.The constituent plasmas source of the product must be derived in line with EU Directive 2002/98/EC of the European Parliament and of the Council — Setting Standards of Quality and Safety for the Collection, Testing, Processing, Storage and Distribution of Human Blood and Blood Components and Amending Directive 2001/83/EC of the European Parliament and of the Council.Additionally source plasma must not be derived from countries who have reported indigenous cases of vCJD.Manufacturing sites must satisfy Eudralex Volume 4, EU Guidance on Good Manufacturing Practice Annex 14.