Canadians with hemophilia A - a rare, inherited blood-clotting disorder - now have a new treatment option with the introduction of XYNTHA(TM), a recombinant factor VIII product for both the control and prevention of bleeding episodes and surgical prophylaxis.
XYNTHA, developed by Wyeth Pharmaceuticals, now a Pfizer company, is produced using state-of-the-art manufacturing and purification processes designed to reduce the risk of viral contamination. It employs true "next-generation" technology, with completely albumin-free manufacturing from start to finish, purification that is completely free of animal-derived materials, and a virus-capturing nanofiltration step.
"XYNTHA is important for hemophilia A patients because it establishes a new standard in recombinant factor VIII product purification technology," says François Therrien, Director, Medical Affairs, Specialty Care Business Unit, Pfizer Canada Inc. "XYNTHA provides the highest level of pathogen safety available - patients can trust that every measure is being employed to ensure their safety."
Until now, the purification process for all recombinant factor VIII products used monoclonal antibodies derived from mouse cell lines. In the manufacture of XYNTHA, the mouse monoclonal antibody is replaced with a synthetic peptide ligand, which was invented by Wyeth scientists.
The nanofiltration step is an additional safety measure that is unique to XYNTHA. It employs a 35 nanometer pore-size filter that is designed to enhance the viral safety profile and provide added assurance to the hemophilia A community.
"We believe the state-of-the-art manufacturing and purification processes used for XYNTHA make it an exciting new therapeutic option for many Canadians with hemophilia A," says Therrien. "It's the culmination of many years of research and development, and demonstrates our continued commitment to the hemophilia community."