Viral safety of B-domain deleted recombinant factor VIII.
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.
Charlebois
T S
TS
Genetics Institute, Cambridge, MA 01810, USA.
O'connell
B D
BD
Adamson
S R
SR
Brink-Nilsson
H
H
Jernberg
M
M
Eriksson
B
B
Kelley
B D
BD
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
C427184:recombinant factor VIII SQ; D005169:Factor VIII