Pharmacokinetic properties of recombinant factor VIII compared with a monoclonally purified concentrate (Hemofil M). The Recombinate Study Group.
A recombinant FVIII preparation, Recombinate, was compared with a high-purity plasma-derived concentrate, Hemofil M, in 47 hemophilia A patients in a cross-over evaluation of pharmacokinetic properties. The recombinant material showed a significantly lower clearance, volume of distribution, and higher in vivo recovery, but a similar half-life to the plasma-based product. In a comparison with reported data from other standard concentrates, the recombinant preparation exhibited potentially better pharmacokinetic properties in that its clearance was slower and its half-life was longer. We conclude that the recombinant DNA method of preparation does not adversely affect the biological and pharmacological characteristics of the factor VIII molecule.
Morfini
M
M
Hematology Department and Hemophilia Center, University of Florence, Italy.
Longo
G
G
Messori
A
A
Lee
M
M
White
G
G
Mannucci
P
P
D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal; D002648:Child; D005169:Factor VIII / Q000302:isolation & purification / Q000493:pharmacokinetics*; D006207:Half-Life; D006467:Hemophilia A / Q000097:blood*; D006801:Humans; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D011994:Recombinant Proteins / Q000493:pharmacokinetics
D000911:Antibodies, Monoclonal; D011994:Recombinant Proteins; D005169:Factor VIII