title: Clinical perspectives of emerging pathogens in bleeding disorders.
abstract: As a result of immunological and nucleic-acid screening of plasma donations for transfusion-transmissible viruses, and the incorporation of viral reduction processes during plasma fractionation, coagulation-factor concentrates (CFC) are now judged safe in terms of many known infectious agents, including hepatitis B and C viruses, HIV, and human T-cell lymphotropic virus. However, emerging pathogens could pose future threats, particularly those with blood-borne stages that are resistant to viral-inactivation steps in the manufacturing process, such as non-lipid-coated viruses. As outlined in this Review, better understanding of infectious diseases allows challenges from newly described agents of potential concern in the future to be anticipated, but the processes of zoonotic transmission and genetic selection or modification ensure that plasma-derived products will continue to be subject to infectious concerns. Manufacturers of plasma-derived CFC have addressed the issue of emerging infectious agents by developing recombinant products that limit the need for human plasma during production. Such recombinant products have extended the safety profile of their predecessors by ensuring that all reagents used for cell culture, purification steps, and stabilisation and storage buffers are completely independent of human plasma.
authors.affiliation: University of Edinburgh, Edinburgh, UK. Christopher.Ludlam@ed.ac.uk
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Ludlam
authors.forename: William G
authors.initials: WG
authors.lastname: Powderly
authors.forename: Samuel
authors.initials: S
authors.lastname: Bozzette
authors.forename: Michael
authors.initials: M
authors.lastname: Diamond
authors.forename: Marion A
authors.initials: MA
authors.lastname: Koerper
authors.forename: Roshni
authors.initials: R
authors.lastname: Kulkarni
authors.forename: Bruce
authors.initials: B
authors.lastname: Ritchie
authors.forename: Jamie
authors.initials: J
authors.lastname: Siegel
authors.forename: Peter
authors.initials: P
authors.lastname: Simmonds
authors.forename: Samuel
authors.initials: S
authors.lastname: Stanley
authors.forename: Michael L
authors.initials: ML
authors.lastname: Tapper
authors.forename: Mario
authors.initials: M
authors.lastname: von Depka
mesh_terms: D000818:Animals; D001779:Blood Coagulation Factors / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D021821:Communicable Diseases, Emerging / Q000635:transmission / Q000821:virology*; D006467:Hemophilia A / Q000150:complications* / Q000628:therapy; D006801:Humans; D011634:Public Health; D014780:Viruses / Q000145:classification / Q000472:pathogenicity*
chemical_list: D001779:Blood Coagulation Factors