Talecris Biotherapeutics' comprehensive safety and quality management programs have ensured that our albumin products continue to exhibit an excellent safety record. The breadth and depth of these measures demonstrate Talecris Biotherapeutics's ongoing commitment to the patients who rely on albumin products.
These methods include:
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Regular inspection of plasma donor centers, three to six times each year
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Strict screening of plasma donors
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Complete donor documentation, including full medical examination and history
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State-of-the-art test methods, including PCR testing for viruses and
Western blot assay (PDF)
for prion clearance
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Four distinct effective steps that complement each other in their mechanism of virus reduction
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Continuous quality control
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No confirmed pathogen transmission in over six decades
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All of the products below are made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. The physician should discuss the risks and benefits of these products with the patient, before prescribing or administering to the patient.
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