Abstract

Steve will talk about the challenges encountered during the development and manufacture of a medical device for the capture and removal of infectious prions from donated blood. The consumption of BSE contaminated beef products in the late 1980’s and early 1990’s gave rise to a new human pathogenic disease – variant Creutzfeldt-Jacob Disease (vCJD). This fatal brain wasting disease has a long incubation time and can be transferred unknowingly from an infected, but outwardly healthy person, to an uninfected person by blood transfusion. The solution to this threat was to develop a unique blood filter, P-CAPT® , a sterile, single-use medical device which incorporates novel affinity ligand technology and novel membrane technology. This has undergone extensive safety and clinical studies and is now in routine use at various locations around the world to improve blood safety. Materials design and biochemical engineering were employed in the development of this product . The importance of a multidisciplinary team approach to problem solving will also be discussed.