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Talecris
Biotherapeutics Becomes First Plasma Fractionator to Perform In-house HBV
Screening Using FDA-Licensed Protocol
Talecris now approved for in-house testing of HIV, HCV, and HBV, further ensuring the safety of its plasma-derived biological therapies RESEARCH TRIANGLE PARK, N.C. (May 26, 2005) — Building on a tradition of leadership in pathogen safety of biological products, Talecris Biotherapeutics has become the first plasma fractionator to use an FDA-licensed test to perform in-house nucleic acid testing (NAT) of hepatitis B (HBV) for source plasma. Moreover, Talecris also is now the first plasma fractionator conducting in-house testing on source plasma for human immunodeficiency virus (HIV), hepatitis C (HCV), and HBV using FDA-approved tests. This provides Talecris with even greater control in confirming the safety of its plasma donations, above and beyond the strict standards and protocols already in place for the screening and donation process. Talecris collaborated with Roche Diagnostics to provide the necessary data to the FDA for consideration of the HBV NAT test. Roche’s FDA-approved Cobas AmpliScreen HBV Test allows for the detection of HBV in whole blood, blood components, and source plasma. Concurrent with Roche’s application to the FDA, Talecris submitted a supplement to its Biologics License Application (BLA) to include Roche’s Cobas AmpliScreen HBV Test for in-house testing of human-source plasma. – more – The Cobas AmpliScreen HBV Test is on par with other testing protocols conducted by commercial laboratories. The testing allows for rapid identification and detection of specific HBV-infected donations, resulting in faster notification to all parties, potentially earlier treatment of the infected donor, and prevention of further donations by that donor. By receiving approval for conducting this testing in-house using the Cobas AmpliScreen HBV Test, Talecris can more directly ensure the integrity of the testing process and the resulting safety of its plasma products. “Approval of this additional test is further demonstration of Talecris’ commitment to provide the safest, most reliable products to our patients,” said Larry Stern, Executive Chairman of Talecris Biotherapeutics. “We are pleased to be an industry leader when it comes to the testing and safety of our plasma, and we will continue to set the standard for our industry.” Douglas C. Lee, Ph.D., Director of Nucleic Acid Technologies (NAT), led the Talecris effort resulting in FDA approval of this new screening protocol. “NAT testing is the state-of-the-art for pathogen detection. Through the use of Roche’s innovative Cobas AmpliScreen Tests, Talecris now screens plasma for HIV, HCV, and HBV in our own laboratories using a state-of-the-art NAT method.” Contact: 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. Information about Talecris can be found at www.talecris.com
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