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.
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.
Vice President Scientific & Medical Affairs, Intensive Care & Emergency Medicine. Octapharma USA, 121 River Street, Hoboken, New Jersey 07030, USA. Electronic address: andrea.neisser-svae@octapharma.com.
Andrea
A
Neisser-Svae
International Consultant in Blood Components Quality/Safety Improvement, Audit/Inspection and DDR Strategy, London, UK. Electronic address: jseghatchian@btopenworld.com.
Jerard
J
Seghatchian
D000818:Animals; D001681:Biological Assay; D001777:Blood Coagulation; D001781:Blood Component Removal; D016913:Blood Component Transfusion; D001798:Blood Proteins / Q000032:analysis; D058731:Blood Safety / Q000379:methods*; D002846:Chromatography, Affinity / Q000379:methods*; D003362:Cost-Benefit Analysis; D003902:Detergents / Q000737:chemistry; D017048:Health Care Costs; D006487:Hemostasis; D006801:Humans; D007221:Industry; D061214:Patient Safety; D010949:Plasma; D017096:Prion Diseases / Q000517:prevention & control* / Q000635:transmission; D011328:Prions / Q000302:isolation & purification*; D012997:Solvents / Q000737:chemistry
D001798:Blood Proteins; D003902:Detergents; D011328:Prions; D012997:Solvents