IMMUNATE S/D - A new Factor VIII - von-Willebrand Factor Complex Concentrate

摘要

No confirmed case of possible, probable, or definite IMMUNATE-related virus transmission has been reported over the 10 years of IMMUNATE's clinical use. For the production of its plasma-derived products, Baxter AG has established a stringent plasma safety program, which goes beyond the requirements laid down in the respective regulations and comprises in addition PCR testing for HIV-l/HIV-2, HCV, HBV, HAV, and PVB19. Current virus inactivation techniques include solvent detergent (S/D) treatment, treatment with polysorbate 80, dry heat treatment and vapor heat treatment [1, 2, 3]. S/D treatment is effective in inactivating lipid-enve-loped viruses [4]. Vapor heat treatment is effective against a broad spectrum of viruses, including non-enveloped viruses such as hepatitis A that are not affected by the S/D treatment [5,6,7,8,9]. To further increase the viral safety margin of the product, the polysorbate 80 step has been replaced with S/D treatment. The resulting product, IMMUNATE S/D, is manufactured by a process otherwise identical to that of IMMUNATE.