title: Update on pathogen inactivation treatment of plasma, with the INTERCEPT Blood System: Current position on methodological, clinical and regulatory aspects.
abstract: After the INTERCEPT Blood System for pathogen inactivation (PI) of plasma was locally validated and approved and is now in routine use in Portugal, a conference was arranged in Portugal, by the IPST, in Coimbra, on 19th November 2014. One of the presentations informed about the current status of the INTERCEPT technology for plasma and a subsequent round table discussion, focused on the methodological and logistical aspects as well as on the experience from clinical studies and routine therapeutic use of INTERCEPT treated plasma units. Moreover, in view of current interests, both the global regulatory issues and hemovigilance data obtained were highlighted. This manuscript provides a brief summary of what has been discussed during presentations and the Q/A round table session. It was agreed between speaker and the moderator of the session to report a consensus opinion on the importance of INTERCEPT to improve the safety of plasma products in a standardized way in terms of quality indicators of hemostasis and the clinical effectiveness as well as the reliability of the technology for plasma pathogen inactivation, to be reported as part of a theme section from Portugal and to be published in Transfusion Apheresis Science in early 2015. The session started showing the beneficial advantages of the INTERCEPT technology, which has already become the standard of practice in Portugal and in more than 20 other countries, and then highlighted some of the methodological and global quality/clinical aspects, which are not usually discussed. We hope the topic discussed here would be of interest to readers of Transfusion Apheresis Science.
authors.affiliation: Cerus BV, Amersfoort, The Netherlands. Electronic address: JIrsch@cerus.com.
authors.forename: Johannes
authors.initials: J
authors.lastname: Irsch
authors.affiliation: International Consultancy in Blood Components Quality/Safety Improvement, Audit/Inspection, and DDR Strategy, London, UK.
authors.forename: Jerard
authors.initials: J
authors.lastname: Seghatchian
mesh_terms: D000890:Anti-Infective Agents / Q000737:chemistry; D001771:Blood Banks / Q000592:standards; D001779:Blood Coagulation Factors; D001781:Blood Component Removal; D001792:Blood Platelets; D058731:Blood Safety / Q000379:methods*; D017848:Blood-Borne Pathogens / Q000302:isolation & purification*; D003140:Communicable Disease Control; D003141:Communicable Diseases / Q000635:transmission; D004203:Disinfection / Q000379:methods; D004867:Equipment Design; D011564:Furocoumarins / Q000737:chemistry; D006801:Humans; D010949:Plasma; D017713:Platelet Transfusion; D011174:Portugal; D014466:Ultraviolet Rays
chemical_list: D000890:Anti-Infective Agents; D001779:Blood Coagulation Factors; D011564:Furocoumarins; C118577:amotosalen