Talecris Announces New Hypermune(TM) Product Safety Advances.
Latex-Free Vials and Syringes and New FDA-Approved Pathogenic Prion prion (prī`ŏn), infectious agent thought to cause a group of diseases known as
prion diseases or transmissible spongiform encephalopathies. Removal Labeling Demonstrate Ongoing Talecris Commitment to Providing Safest Possible Protein Therapies
RESEARCH TRIANGLE PARK Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , N.C. -- Talecris Biotherapeutics, Inc. (http://www.talecris.com) announced today that as of October 1, 2007, all new releases of its line of Hypermunes(TM) (hyperimmune globulin hyperimmune globulin An Ig concentrate with high titers of antibodies against an antigen of interest therapies) are latex-free. With the elimination of latex from the vial rubber stoppers and prefilled syringes, physicians can confidently use Talecris' Hypermunes in their patients with latex allergy. This latest action represents the ongoing Talecris effort to support "latex-free" medical environments.
Talecris is the only manufacturer with a full line of hyperimmune hyperimmune /hy·per·im·mune/ (hi?per-i-mun´) possessing very large quantities of specific antibodies in the serum.
possessing very large quantities of specific antibodies in the serum. products including HyperRHO[TM] S/D S/D Shutdown
S/D System Description
S/D Same Difference
S/D Social Drinker
S/D Shifta/Deband (gaming) (Rho (D), Immune Globulin [Human]), HyperTET[TM] S/D (Tetanus Immune Globulin tetanus immune globulin
A sterile solution of globulins that are derived from the blood plasma of adult human donors who exhibit a high titer of antibodies specific for tetanus because of immunization with tetanus toxoid, used as a passive [Human]), HyperRAB[TM] S/D (Rabies Immune Globulin rabies immune globulin
Specific immune globulin from human donors immunized against rabies. [Human]), HyperHEP B[TM] S/D (Hepatitis B Immune Globulin [Human]), and GamaSTAN[TM] S/D (Immune Globulin [Human]).
In addition to announcing its latex-free hyperimmune line, Talecris also has received approval from the Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) to include hyperimmune labeling information related to removal during manufacturing of pathogenic prions, including those associated with variant Creutzfeldt-Jakob disease (vCJD, the human form of "mad cow" disease). This new labeling was approved based on studies conducted with an experimental agent of transmissible spongiform encephalopathy Transmissible spongiform encephalopathies (TSEs, also known as prion diseases) are a group of progressive conditions that affect the brain and nervous system of humans and animals and are transmitted by prions. (TSE See Tokyo Stock Exchange.
1. See Tokyo Stock Exchange (TSE).
2. See Toronto Stock Exchange (TSE). ), considered to be a model for vCJD, demonstrating that 6.7 log10 are removed (99.9999% of any pathogenic prions present). As a result, patients and healthcare providers have new, reasonable assurance that the Talecris hyperimmune manufacturing process has demonstrated its ability to remove pathogenic prions.
"Product safety remains a top priority at all levels of our research and manufacturing organizations," said Steve Petteway, Ph.D., Senior Vice President, Research & Development, Talecris Biotherapeutics. "These two advances provide an improved overall margin of safety for our Hypermunes. Moreover, the pathogenic prion labeling further demonstrates our leadership position in conducting pathogen safety research and applying manufacturing technologies."
About the Talecris Hypermune Line of Products
Talecris' hyperimmune globulin therapies are concentrated immunoglobulins used to treat patients whose immune systems have been compromised or challenged. To optimize protection, the greatest benefit comes from combining both active and passive immunization. Talecris Biotherapeutics' hyperimmune globulin products provide rapid passive immunity in the post-exposure period. When appropriate, concomitant vaccination will initiate an active immune response. Together, these therapies provide optimum immune protection. Hyperimmune globulin therapy (passive immunization) offers rapid immune protection after exposure. The Talecris Hyperimmune globulins contain high titers of specific antibodies and are available for prophylaxis against:
* Hepatitis A -- (GamaSTAN[TM] S/D, Immune Globulin [Human]). The use of GamaSTAN[TM] S/D for pre-exposure prophylaxis to hepatitis A is recommended.
* Hepatitis B -- (HyperHEP B[TM] S/D, Hepatitis B Immune Globulin [Human])
* Rabies -- (HyperRAB[TM] S/D, Rabies Immune Globulin [Human])
* Rh sensitization -- (HyperRHO[TM] S/D, Rho (D), Immune Globulin [Human]) and viral infections such as measles (rubeola rubeola: see measles. )
* Tetanus -- (HyperTET[TM] S/D, Tetanus Immune Globulin [Human])
The Hypermunes may be used as prophylaxis in combination with a specific vaccine, when appropriate. Constant monitoring in steps of the manufacturing and delivery processes makes these biological products safe, easy, and convenient to use. As with all plasma derived therapeutics, the potential to transmit infectious agents, such as viruses, cannot be totally eliminated. For additional information on Hypermunes, please see full prescribing information for each product at www.hypermunes.com.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology pul·mo·nol·o·gy
The branch of medicine that deals with diseases of the respiratory system.
pulmonology The study of the lungs and respiratory function , and hemostasis hemostasis /he·mo·sta·sis/ (he?mo-sta´sis) (he-mos´tah-sis)
1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means.
2. . Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners.
Talecris, which earned revenues exceeding $1.1 billion in 2006, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 3,000 talented people worldwide.
To learn more about Talecris and how our employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com.