Talecris Biotherapeutics' Manufacturing Processes Safeguard Against 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 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.
SOURCE: Talecris Biotherapeutics