The state of the art of removal of prion proteins in SD-FFP, by specific prion affinity chromatography and its impact on the hemostatic characteristics of the product

Abstract

In recent Coimbra' Conference, on the pre-launch of pathogen reduced-FFP for the local clinical use, the question was raised, by the moderator, on the efficacy of the current methodology used for prion removal processes and its influence on the overall quality and safety of the final product. This brief paper put together by speaker of this session and the moderator, as a consensus of opinions, which was largely discussed during Q&A session, to make it available to a large group of readers of transfusion apheresis science, who might be interested to this topic. In short the capacity of the current process of Octaplas to remove prion is in order of 5.6 log10/ID50 reduction based on several animal studies. Moreover the changes in coagulation and inhibitors are within acceptable range and bioequivalent to untreated FFP with no sign of inferiority. This paper describes in brief a technology update on solvent/detergent treated plasma, an alternative to FFP but with increased pathogen safety. The biochemical profile of the final product is comparable with FFP and contains all clinically relevant plasma proteins. Furthermore, Octaplas is a product that, in long term, reduces health care costs.

Pathogen reduction/inactivation of products for the treatment of bleeding disorders: what are the processes and what should we say to patients?

“…More recent efforts to increase the efficiency of prion removal in blood have focused on the development of prion removal filters. However, most of these filters have been evaluated on blood spiked with hamster brain infected with a scrapie-derived prion strain (263K) [98–100]. It is highly unlikely that the physicochemical properties of these brain-derived prion spikes mimic those of prions in the blood of individuals infected with vCJD.…”

Resuscitation of Endotheliopathy and Bleeding in Thoracic Aortic Dissections: The VIPER-OCTA Randomized Clinical Pilot Trial

“… 20 – 24 Importantly, OctaplasLG ® is free of cells and debris due to several steps of microfiltration, of which one is a dedicated cell filtration (1 μm) step, during manufacturing, in addition to inactivation of viruses, and the removal of bacteria, parasites, and prion proteins. 25 , 26 …”