Pall Prion Removal Technology Presented to FDA Blood Products Advisory Committee

22-Mar-2005

Pall Corporation presented an overview of the latest research on its prion reduction technology as a new risk reduction measure to help prevent transfusion transmission of infectious prions that can cause vCJD. The Company expects to launch the new filter commercially in Europe this spring.

TSEs, also called prion diseases, are fatal neurodegenerative diseases that include vCJD in humans; bovine spongiform encephalopathy (BSE) in cattle; chronic wasting disease (CWD) in deer, elk and moose; and scrapie in sheep. These diseases are believed to be caused by prions, which are misfolded, or "rogue", infectious proteins.

"So much remains unknown about prion diseases even as new information comes to light practically daily. No one really knows how many people may be harboring vCJD without clinical symptoms and could potentially transmit the infection via blood transfusion," according to Joseph Cervia, MD, medical director of Pall Corporation.

The Pall Leukotrap® Affinity Prion Reduction Filter simultaneously reduces leukocytes (white blood cells) and all types of prions from red blood cells in a single step. Red cells are the most widely transfused blood component. Leukoreduction of blood is approximately 40 percent effective in reducing risk of vCJD infection, but is not sufficient since prions can be both cell-associated (in leukocytes) and non-cell associated.

Dr. Cervia described the results of studies that show the novel technology concurrently reduces both leukocytes and prions (cell and non- cell associated) from red cell concentrates with a 99 percent reduction of the infectious agent. The research, conducted with vCJD and scrapie prions, showed that the new filter removed the infectious prions to below the limit of detection of the Western blot assay. Dr. Cervia also described the results of studies demonstrating that the filter does not damage red cells thereby not impacting their efficacy, purity and therapeutic value.

Following CE mark and commercialization of the filter in Europe, Pall Corporation plans to discuss this technology with regulatory agencies in Canada and the U.S. The Company is also studying the new filter as a device to aid in the detection of BSE in cattle before entering the food supply.

https://www.bionity.com/en/news/44569/pall-prion-removal-technology-presented-to-fda-blood-products-advisory-committee.html