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The development of a cell bank used in the routine manufacturing of a B-domain deleted recombinant coagulation factor VIII (BDDrFVIII) molecule involved stable insertion of the human BDDrFVIII gene into Chinese hamster ovary (CHO) cells, selection of a cell line capable of expressing consistent levels of active BDDrFVIII, and the establishment of a cell bank. The manufacturing process begins with the culturing of CHO cells in large bioreactors. Product synthesis is initiated by altering the cell culture conditions, thereby arresting the cells in a stationary growth phase and inducing elevated expression of BDDrFVIII. Harvested culture medium is concentrated by chromatography and then purified through a series of four column chromatography steps and one solvent-detergent virus inactivation step. By eliminating the presence of human serum albumin in the final formulation, the BDDrFVIII-containing coagulant product meets with a high standard of safety against microbial and viral contamination. Extensive studies have shown that BDDrFVIII is a consistent, highly pure factor VIII for the treatment of patients with hemophilia A.
R K Eriksson, and
C Fenge, and
E Lindner-Olsson, and
C Ljungqvist, and
J Rosenquist, and
A L Smeds, and
A östlin, and
T Charlebois, and
M Leonard, and
B D Kelley, and
A Ljungqvist
July 1997,
Thrombosis and haemostasis,
R K Eriksson, and
C Fenge, and
E Lindner-Olsson, and
C Ljungqvist, and
J Rosenquist, and
A L Smeds, and
A östlin, and
T Charlebois, and
M Leonard, and
B D Kelley, and
A Ljungqvist
April 2001,
Seminars in hematology,
R K Eriksson, and
C Fenge, and
E Lindner-Olsson, and
C Ljungqvist, and
J Rosenquist, and
A L Smeds, and
A östlin, and
T Charlebois, and
M Leonard, and
B D Kelley, and
A Ljungqvist
April 2001,
Seminars in hematology,
R K Eriksson, and
C Fenge, and
E Lindner-Olsson, and
C Ljungqvist, and
J Rosenquist, and
A L Smeds, and
A östlin, and
T Charlebois, and
M Leonard, and
B D Kelley, and
A Ljungqvist
April 2001,
Seminars in hematology,
R K Eriksson, and
C Fenge, and
E Lindner-Olsson, and
C Ljungqvist, and
J Rosenquist, and
A L Smeds, and
A östlin, and
T Charlebois, and
M Leonard, and
B D Kelley, and
A Ljungqvist
June 2002,
Seminars in thrombosis and hemostasis,
R K Eriksson, and
C Fenge, and
E Lindner-Olsson, and
C Ljungqvist, and
J Rosenquist, and
A L Smeds, and
A östlin, and
T Charlebois, and
M Leonard, and
B D Kelley, and
A Ljungqvist
April 2001,
Seminars in hematology,
R K Eriksson, and
C Fenge, and
E Lindner-Olsson, and
C Ljungqvist, and
J Rosenquist, and
A L Smeds, and
A östlin, and
T Charlebois, and
M Leonard, and
B D Kelley, and
A Ljungqvist
January 2002,
Developments in biologicals,
R K Eriksson, and
C Fenge, and
E Lindner-Olsson, and
C Ljungqvist, and
J Rosenquist, and
A L Smeds, and
A östlin, and
T Charlebois, and
M Leonard, and
B D Kelley, and
A Ljungqvist
January 2000,
Bioconjugate chemistry,
R K Eriksson, and
C Fenge, and
E Lindner-Olsson, and
C Ljungqvist, and
J Rosenquist, and
A L Smeds, and
A östlin, and
T Charlebois, and
M Leonard, and
B D Kelley, and
A Ljungqvist
October 1992,
Transfusion medicine reviews,
R K Eriksson, and
C Fenge, and
E Lindner-Olsson, and
C Ljungqvist, and
J Rosenquist, and
A L Smeds, and
A östlin, and
T Charlebois, and
M Leonard, and
B D Kelley, and
A Ljungqvist
June 2007,
The AAPS journal,
