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November 09, 2005 12:00 PM US
Biotherapeutics' Manufacturing Processes Safeguard Against Avian
Bird Flu; Processes Assure Inactivation of Enveloped Viruses
Like H5N1, Preventing Potential Transmission Through Talecris'
Therapeutic Plasma Proteins
RESEARCH TRIANGLE PARK,
N.C.--(BUSINESS WIRE)--Nov. 9, 2005--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.
"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
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 used clinically."
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.
About Talecris Biotherapeutics
Talecris is a newly formed company
with the assets and history of Bayer HealthCare Biological
Products Division's plasma business. With global headquarters in
Research Triangle Park, N.C., primary manufacturing facilities
for Talecris products in Clayton, N.C., and additional
fractionation and manufacturing facilities of Precision Pharma
Services in Melville, N.Y., Talecris employs nearly 1700 people.
Inheriting a legacy of more than
60 years of providing lifesaving and life-enhancing
plasma-derived therapeutic proteins, Talecris is well positioned
to become recognized as the global leader in developing and
delivering premium protein products. Through its people,
technology, and state-of-the-art facilities, Talecris will build
on this long history of innovation through a focused,
entrepreneurial approach to new product development, application
of cutting-edge manufacturing technologies, and marketing and
customer service. Talecris is talented industry professionals
providing critical care treatments and services for patients,
while maintaining a vision for the future of care.
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