title: Viral safety of B-domain deleted recombinant factor VIII.
abstract: The possible transmission of blood-borne pathogens has been the impetus behind the development of recombinant products formulated in the absence of human-derived components. The viral safety of Chinese hamster ovary (CHO)-cell-based pharmaceuticals is well established. Over 100 million infusions have been administered without a single known incident of CHO-related viral transmission. The manufacturing process for B-domain deleted recombinant factor VIII (BDDrFVIII) builds on this safety record by using a state-of-the-art multitiered approach to viral safety. This approach includes: (1) extensive testing of the CHO cells used to produce BDDrFVIII; (2) routine viral monitoring of the cell culture production process; (3) a purification process in which a specific viral inactivation procedure has been included; (4) a final formulation that does not incorporate human albumin as the stabilizer; and (5) a thorough validation of the viral inactivation and removal capacity of the purification process. This multifaceted viral safety program offers the hemophilia community a factor VIII product with an exceptional degree of viral safety.
authors.affiliation: Genetics Institute, Cambridge, MA 01810, USA.
authors.forename: T S
authors.initials: TS
authors.lastname: Charlebois
authors.forename: B D
authors.initials: BD
authors.lastname: O'connell
authors.forename: S R
authors.initials: SR
authors.lastname: Adamson
authors.forename: H
authors.initials: H
authors.lastname: Brink-Nilsson
authors.forename: M
authors.initials: M
authors.lastname: Jernberg
authors.forename: B
authors.initials: B
authors.lastname: Eriksson
authors.forename: B D
authors.initials: BD
authors.lastname: Kelley
mesh_terms: D000818:Animals; D016466:CHO Cells / Q000821:virology; D003257:Consumer Product Safety; D006224:Cricetinae; D005169:Factor VIII / Q000302:isolation & purification / Q000592:standards*; D006801:Humans; D008420:Manufactured Materials / Q000821:virology*; D013242:Sterilization / Q000379:methods
chemical_list: C427184:recombinant factor VIII SQ; D005169:Factor VIII