Applications & Products
Pathogen Reduction
Technology for Capture and Removal of Prion
ProMetic has established a joint-venture with the American Red Cross - Pathogen Removal and Diagnostic Technologies (“PRDT”) – to develop new and improved technologies for the removal and detection of pathogens from blood and blood products. The first products to emerge from the PRDT joint-venture collaboration are specific affinity adsorbents for the capture and removal of infectious prion proteins.
Prions are transmissible infectious agents responsible for BSE in cattle, scrapie in sheep and vCJD in humans. These fatal degenerative brain diseases are characterised by an accumulation of abnormal prion protein in the central nervous system and may be transmitted by ingestion of contaminated meat or transfusion of contaminated blood. There is a particular concern regarding secondary transmission of vCJD by means of contaminated blood or blood-derived products such as red cells, platelets, plasma and plasma proteins. Initial estimates indicate there may be in the region of 3,800 carriers of vCJD in the UK and, to date, there have been 4 cases of vCJD transmission from transfusion of contaminated red cells. In the absence of any approved test for determination of vCJD in blood, prion capture and removal currently represents the only defence against secondary transmission.
To protect against the risk of vCJD transmission, PRDT has developed a panel of affinity adsorbents that enable the highly effective capture and reduction of infectious prion proteins from a range of biological materials including, blood, red cell concentrate, plasma and plasma proteins.
PRDT prion reduction resins, available exclusively from ProMetic, are capable of removing > 7 log10 infectivity (ID50) per ml of sample. Prion reduction has been demonstrated for a number of different prion species and validated with both exogenous (brain derived) and endogenous (blood-derived) infectivity. PRDT technology forms the basis of the revolutionary P-Capt® filter, a prion reduction device developed with ProMetic’s commercialization partner MacoPharma. P-Capt® has received CE mark approval in Europe, and provides a means of significantly reducing the risk of vCJD transmission through blood transfusion. This product is currently undergoing multi-centre evaluations (pre-adoption studies) by the National Blood Transfusion Services of the United Kingdom and Ireland.
Additionally, Octapharma AG has incorporated a PRDT prion removal resin into the manufacturing process for OctaplasLG® (Solvent/Detergent treated plasma) to further improve the prion safety margin for this biopharmaceutical product. OctaplasLG® has obtained regulatory approval in Germany.
For more information on prion reduction products and technology, please contact us at sales@prometicbiosciences.com.
