title: Highlights of PBTI Coimbra Conference on PRT of Plasma & Current Opinions on Pathogen Reduction Treatment of Blood Components.
abstract: Two experts from Octapharma and from Cerus addressed, in very concise ways, the concerns about non-viral inactivated FFP and how they managed to obtain highest standard of safety margin for pathogen reduction treatment [PRT] of plasma. The session was moderated by Portuguese Institute of Blood and Transplantation (PIBT) consultant advisor [Jerard Seghatchian] with long standing familiarity and international recognition in PR technologies for plasma, platelets and WB/red cells. The focus of conference was mainly on the criteria of acceptability of PRT-FFP; added values of having diversity in choice without fears of liability, as both of PRT technologies provide an excellent safeguard margins, for more than a decade of usage. In most European countries, it is believed that patients' safety come first followed by the safe usage initiatives, in particular using locally available products. Portugal is finally going forward with the implementation PRT plasma using its own FFP for their clinical use. The round table Q&A session focused on the impacts of the additional processing, which is still continuously improving, on the residual/emerging pathogen infectivity; eliminating the clinical impacts of donors viable leukocytes; the degree of altered product potency in particular cold activation of FVII; and loss of endothelial permeability factors during fluid storage of plasma. Both speakers highlighted their product safety and clinical efficacy using both routine in vitro, including the modern proteomic tests to establish the relevant changes in various parameters and in the overall clinical outcomes. The advancements in pharmacovigilance and hemovigilance, regulatory aspects and cost effectiveness were also highlighted. A local speaker [from the PIBT] described the state of the art of local processing issues and overall required standards used both during validation and the intercept process scale up, which is going ahead smoothly to providing the highest safety standards PRT-intercept plasma locally, in production now. Overall this was an excellent conference, open to transfusion medicine specialists and other health care professionals, for feedback and quality awareness, of providing diversity in choice, to local clinicians, who demand the best for the ultimate patient requirements. This is achieved in a period where both cost effectiveness and affordability matter, so is the clinical outcome, which ultimately counts. There was an atmosphere of non-competitive collaboration and sharing knowledge and working togetherness, even between two manufacturer representatives, which made the conference most joyful event. This was the opportunity to the scientific update and sharing "the once upon a time" impossible task of going for PRT-plasmas in Portugal, making it a reality in their local setting, in real time using Portuguese plasmas. This is in fact the timely news in the period of austerity, to provide a pre launching session for reporting the state of the arts of Portugal achievements to staff, academician, laboratory experts and clinician alike.
authors.affiliation: PIBT Directive Board, Av Miguel Bombarda, no 6, 1000-208 Lisbon, Portugal. Electronic address: gracinda.sousa@ipst.min-saude.pt.
authors.forename: Gracinda
authors.initials: G
authors.lastname: de Sousa
authors.affiliation: International Consultant in Blood Component Quality/Safety, Audit/Inspection & DDR Strategy, London, UK. Electronic address: jseghatchian@btopenworld.com.
authors.forename: Jerard
authors.initials: J
authors.lastname: Seghatchian
mesh_terms: D016913:Blood Component Transfusion / Q000191:economics / Q000379:methods* / Q000592:standards / Q000639:trends*; D001792:Blood Platelets; D058731:Blood Safety; D003362:Cost-Benefit Analysis; D006801:Humans; D061214:Patient Safety; D010949:Plasma; D011174:Portugal; D011786:Quality Control; D016896:Treatment Outcome