Continuing its commitment to providing reliable supplies of the safest possible products,
Talecris BioTherapeutics has confirmed its
plasma collection and manufacturing processes significantly remove or inactivate enveloped
viruses, such as those belonging to the
influenza virus family, including the H5N1 virus associated with avian bird flu. With this announcement, patients and physicians can feel confident that transmission of the avian bird flu virus, a current public health concern, is extremely unlikely to occur with the use of Talecris plasma-derived
therapeutic proteins.
The virus associated with avian bird flu, H5N1, is an influenza virus. These viruses are relatively large
and are known as "enveloped" viruses; that is, they have a lipid envelope that surrounds the genetic
material of the virus. Concerns over the potential pandemic that have been the subject of recent news
reports prompted Talecris to assess whether the plasma-derived therapeutic proteins it manufactures could carry a risk of transmission for patients.
Pathogen safety scientists at Talecris Biotherapeutics have been pioneers in developing processes
that remove or inactivate viral and other infectious particles, including the pathogenic prion
associated with variant
Creutzfeldt-Jakob disease. Over the past several years, Talecris has led the way with research demonstrating
Removal or inactivation of viruses, such as
West Nile Virus, vaccinia (the virus used in
smallpox vaccinations), and human
immunodeficiency virus (HIV) from plasma-derived therapies. Additionally, the industry-leading work in the area of pathogenic
prions has resulted in the
FDA allowing clearance data to be included in product package inserts. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be
totally eliminated.