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Independent industry organization recognizes Talecris' commitment to providing patients with safe and high-quality therapeutic protein therapies
RESEARCH TRIANGLE PARK, N.C. (Oct. 4, 2005) — Talecris Biotherapeutics has been awarded Quality Standards of Excellence, Assurance, and Leadership (QSEAL) certification from the Plasma Protein Therapeutics Association (PPTA). QSEAL recognizes industry leaders that voluntarily implement safety standards beyond regulatory requirements to enhance the safety and quality of their life-saving plasma protein therapies.
"Talecris has an unparalleled history of leadership in safety and product integrity, and the QSEAL certification provides affirmation of this commitment," said Talecris Executive Chairman Larry Stern. "We use a multi-faceted approach to help ensure the patient communities we serve receive the safest, highest-quality products possible. Talecris will uphold the standards required to meet QSEAL certification, and we will continue to set new industry standards for the safety and quality of biological products."
The QSEAL certification is awarded based on an independent evaluation of four standards that reduce the possibility of at-risk plasma donations entering the manufacturing pool for plasma protein therapies. Certification means Talecris meets the standards for strict criteria for selection of qualified donors; implementation of a 60-day inventory hold to allow time to identify and destroy any suspect plasma donations so they do not enter the manufacturing process; use of NAT (Nucleic acid Amplification Technology) testing to detect certain viruses even earlier than currently licensed serological screening technology; and the use of viral markers to assure plasma is collected from low-risk populations.
This is the first QSEAL certification awarded to Talecris Biotherapeutics. The company's predecessor,
Bayer Biological Products, received QSEAL certification in 2001 — the first year PPTA awarded
QSEAL certification to plasma therapies manufacturers. All of the Talecris facilities received the
QSEAL certification, including its primary manufacturing facility in Clayton, N. C.; its plasma testing
facility in Raleigh, N. C.; and Precision Pharma's fractionation and contract manufacturing facility in
Melville, N. Y. The certification is effective, pending required audits, through Sept. 2007.
"We congratulate Talecris for successfully meeting the criteria of QSEAL certification," said
Julie Birkofer, Executive Director, North America, PPTA. "Talecris continues to distinguish itself as an
industry leader through its commitment to safe, high-quality plasma-derived products that safeguard the
health of the consumers who rely on their treatments."
Contact: Lacy McMahon Tel.: 919-316-6316, Fax: 919-316-6673 E-mail: lacy.mcmahon@talecris.com
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 1,700 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.
Information about Talecris can be found at www.talecris.com. To receive e-mail updates when new information is added to the Talecris Web site, please register at www.talecris.com/media_contact.cfm.
About PPTA
The Plasma Protein Therapeutics Association (PPTA) (www.pptaglobal.org) is the primary advocate for the world's leading source plasma collectors and producers of plasma-based and recombinant biological therapeutics. As the global representative for the plasma collection and therapeutics industry, PPTA works cooperatively with patient groups, policymakers, regulatory agencies, and other stakeholders to address critical issues that impact the industry and patients who depend on plasma protein therapeutics.
Important Safety Information
Prolastin®, Alpha1-Proteinase Inhibitor (Human) is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha-1 PI (alpha1-antitrypsin deficiency) with clinically demonstrable panacinar emphysema. Weekly Prolastin® therapy has demonstrated a low occurrence of side effects. In clinical studies with Prolastin®, reactions were observed in 1.16% of infusions, the most common events being fever (0.77%), light-headedness (0.19%), and dizziness (0.19%). As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. Individuals with selective IgA deficiencies who have known antibody against IgA (anti-IgA antibody) should not receive Prolastin®, since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please click here for Prolastin® full Prescribing Information.
Remember, your doctor or healthcare provider is the single best source of information regarding you and your health. Please consult your doctor or healthcare provider if you have any questions about your health or any of your medications.
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