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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.
T S Charlebois, and
B D O'connell, and
S R Adamson, and
H Brink-Nilsson, and
M Jernberg, and
B Eriksson, and
B D Kelley
July 1997,
Thrombosis and haemostasis,
T S Charlebois, and
B D O'connell, and
S R Adamson, and
H Brink-Nilsson, and
M Jernberg, and
B Eriksson, and
B D Kelley
April 2001,
Seminars in hematology,
T S Charlebois, and
B D O'connell, and
S R Adamson, and
H Brink-Nilsson, and
M Jernberg, and
B Eriksson, and
B D Kelley
April 2001,
Seminars in hematology,
T S Charlebois, and
B D O'connell, and
S R Adamson, and
H Brink-Nilsson, and
M Jernberg, and
B Eriksson, and
B D Kelley
April 2001,
Seminars in hematology,
T S Charlebois, and
B D O'connell, and
S R Adamson, and
H Brink-Nilsson, and
M Jernberg, and
B Eriksson, and
B D Kelley
June 2002,
Seminars in thrombosis and hemostasis,
T S Charlebois, and
B D O'connell, and
S R Adamson, and
H Brink-Nilsson, and
M Jernberg, and
B Eriksson, and
B D Kelley
April 2001,
Seminars in hematology,
T S Charlebois, and
B D O'connell, and
S R Adamson, and
H Brink-Nilsson, and
M Jernberg, and
B Eriksson, and
B D Kelley
February 1997,
Thrombosis and haemostasis,
T S Charlebois, and
B D O'connell, and
S R Adamson, and
H Brink-Nilsson, and
M Jernberg, and
B Eriksson, and
B D Kelley
January 2002,
Developments in biologicals,
T S Charlebois, and
B D O'connell, and
S R Adamson, and
H Brink-Nilsson, and
M Jernberg, and
B Eriksson, and
B D Kelley
January 2000,
Bioconjugate chemistry,
T S Charlebois, and
B D O'connell, and
S R Adamson, and
H Brink-Nilsson, and
M Jernberg, and
B Eriksson, and
B D Kelley
April 2001,
Seminars in hematology,
