Research Triangle Park, NC -- 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.
"This is very reassuring news for patient communities who rely on
Talecris products," said John W. Walsh, President, CEO, and co-founder
of the Alpha-1 Foundation, a not-for-profit corporation, dedicated to
providing the leadership and resources that will result in increased
research, improved health, worldwide detection, and a cure for Alpha-1
Antitrypsin Deficiency, a genetic disorder that can cause liver and
lung disease in children and adults. "Collectively, the industry and
the patient and treater communities have to remain diligent to
maintain the safety of life-saving and life-enhancing biological
products from known and emerging pathogens."
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.
"As an R&D organization, our goal is to ensure that our products
have the highest possible margin of safety against known pathogens and
emerging concerns such as avian bird flu, which potentially could find
its way into plasma donor pools," said Stephen R. Petteway, Jr.,
Ph.D., Senior Vice President, Research and Development, Talecris
Biotherapeutics. "We approach product safety as a matrix process
touching all stages of manufacturing including plasma procurement, our
own in-house nucleic acid testing for key viruses, and our
manufacturing processes that inactivate or remove pathogens from the
final product. Furthermore, we maintain the highest possible
marketplace scrutiny through our medical surveillance as products are
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 (formerly a unit of Bayer HealthCare's Biological Products
Division) 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.
SOURCE: Talecris Biotherapeutics