Selection of spiking materials for studies on the clearance of agents of transmissible spongiform encephalopathy during plasma fractionation.

摘要

Manufacturers of plasma derivatives are encouraged to perform product-specific investigational studies on the ability of their processes to remove prion agents. Such studies are invariably performed using spiking materials derived from infected brain tissue. However, there is little guidance available on which preparations are suitable and no consensus on the acceptability of resultant data. Further research is required to resolve this question. Standardization