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Commitment to Safety. Talecris Research

Continuing research efforts on Talecris Biotherapeutics Albumin Products include:

Identifying emerging pathogens
Continuing the rigorous scientific evaluation of the pathogen safety profile
Investigating new techniques for pathogen removal and inactivation

Talecris Biotherapeutics' pathogen safety and research groups continue to explore virus reduction methods targeted at all known classes of viruses to anticipate currently unknown pathogens. These steps will ensure a safe and reliable supply of albumin for our customers.

Validated West Nile Virus Clearance Steps
Process StepsReduction Factor (log10)
Precipitation/acetone suspension≥6.0
Pasteurization (5% Albumin)≥7.4
Pasteurization (20%/25% Albumin)≥6.7

The ongoing research conducted by Talecris Biotherapeutics helps alleviate concerns over pathogenic prion proteins1 and assures both physicians and patients that Talecris Biotherapeutics Albumin Products continue to be free of viral contamination.

Screening Method
Virus Reduction
Prion Clearance

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.

Reference

1.   Lee DC, Stenland CJ, Miller JLC, et al. A direct relationship between the partitioning of the pathogenic prion protein and transmissible spongiform encephalopathy infectivity during the purification of plasma proteins. Transfusion. 2001;41:449-455.

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