title: Decontamination of prions in a plasma product manufacturing environment.
abstract: BACKGROUND
  The high resistance of prions to inactivating treatments requires the proper management of decontaminating procedures of equipment in contact with materials of human or animal origin destined for medical purposes. Sodium hydroxide (NaOH) is widely used today for this purpose as it inactivates a wide variety of pathogens including prions.
  
  
  METHODS
  Several NaOH treatments were tested on prions bound to either stainless steel or chromatographic resins in industrial conditions with multiple prion strains.
  
  
  RESULTS
  Data show a strong correlation between inactivation results obtained by immunochemical detection of the prion protein and those obtained with infectivity assays and establish effective inactivation treatments for prions bound to stainless steel or chromatographic resins (ion exchange and affinity), including treatments with lower NaOH concentrations. Furthermore, no obvious strain-specific behavior difference was observed between experimental models.
  
  
  CONCLUSIONS
  The results generated by these investigations show that industrial NaOH decontamination regimens (in combination with the NaCl elution in the case of the chromatography process) attain substantial prion inactivation and/or removal between batches, thus providing added assurance to the biologic safety of the final plasma-derived medicinal products.
authors.affiliation: LFB, Les Ulis, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Bellon
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Comoy
authors.forename: Steve
authors.initials: S
authors.lastname: Simoneau
authors.forename: Sandrine
authors.initials: S
authors.lastname: Mornac
authors.forename: Capucine
authors.initials: C
authors.lastname: Dehen
authors.forename: Audrey
authors.initials: A
authors.lastname: Perrin
authors.forename: Aude
authors.initials: A
authors.lastname: Arzel
authors.forename: Samuel
authors.initials: S
authors.lastname: Arrabal
authors.forename: Henry
authors.initials: H
authors.lastname: Baron
authors.forename: Hubert
authors.initials: H
authors.lastname: Laude
authors.forename: Bruno
authors.initials: B
authors.lastname: You
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Deslys
authors.forename: Benoit
authors.initials: B
authors.lastname: Flan
mesh_terms: D000818:Animals; D000094902:Blood Banking / Q000379:methods; D006224:Cricetinae; D003666:Decontamination / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004780:Environment, Controlled; D004866:Equipment Contamination / Q000517:prevention & control; D006801:Humans; D008420:Manufactured Materials; D008647:Mesocricetus; D051379:Mice; D010949:Plasma / Q000737:chemistry*; D011328:Prions / Q000302:isolation & purification*; D012972:Sodium Hydroxide / Q000494:pharmacology; D013193:Stainless Steel
chemical_list: D011328:Prions; D013193:Stainless Steel; D012972:Sodium Hydroxide