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news.Wyeth Pharmaceuticals, a division of Wyeth, has announced that product shipments have begun for Xyntha antihemophilic factor, plasma/albumin-free, a new recombinant factor VIII product for both the control and prevention of bleeding episodes and surgical prophylaxis in patients with hemophilia A, a rare, inherited blood-clotting disorder.
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Xyntha is produced using manufacturing and purification processes designed to reduce the risk of viral contamination. The manufacturing process for Xyntha is completely albumin-free from start to finish, while the purification process utilizes a unique synthetic ligand totally free of animal materials and a nanofiltration step using a 35 nanometer pore-size filter.
As an added convenience for patients, Wyeth’s one-of-a-kind rapid reconstitution (R2) kit is provided with Xyntha. The R2 Kit is designed to help patients save time by allowing for ease of transportation and fewer steps during rapid reconstitution.
Shipments of the company’s current recombinant factor VIII product, ReFacto antihemophilic factor in the US will be discontinued as of May 31, 2009.
Robert Repella, executive vice-president and general manager of Wyeth BioPharma, said: “The introduction of Xyntha is the culmination of many years of R&D, and demonstrates Wyeth’s continued commitment to the hemophilia community.”