CSL Behring Adds Isoagglutinin Reduction Step to Privigen® Manufacturing Process
CSL Behring integrates an immunoaffinity chromatography step designed to lower isoagglutinin levels in its intravenous polyvalent immunoglobulin therapies.
BERN, SWITZERLAND — 24 February 2016
Global biotherapeutics leader CSL Behring today announced an enhancement to its manufacturing process for Privigen® with the addition of the Ig IsoLo® step. Ig IsoLo is an immunoaffinity chromatography (IAC) step which reduces the content of antibodies to blood groups A and B antigens (isoagglutinins) in Privigen. These antibodies are known to play a role in the occurrence of haemolysis, a rare condition marked by the rupture of red blood cells and the release of their contents into the plasma, which is a known adverse event associated with the immunoglobulin (Ig) class of therapy. Privigen manufactured with the Ig IsoLo step will be among a group of IVIGs with low levels of isoagglutinins.
“This addition to our Privigen manufacturing process is a prime example of the company’s promise of continuous improvement to our products, including product safety,” says Val Romberg, Executive Vice President, Manufacturing and Planning. He adds, “Every step in our manufacturing processes reflects our strong commitment to ensuring we continue to deliver safe, effective therapies to our patients.”
CSL Behring manufactures Privigen at its state-of-the art facilities in Bern, Switzerland, and
Melbourne, Australia, where the most advanced technologies are applied to ensure product safety and supply. These facilities represent the long-term commitment of CSL Behring to patients all over the world requiring immunoglobulin therapy. The Ig IsoLo step is approved by health authorities in the United States, Europe, Canada, Australia, Switzerland and other select countries. From the end of March 2016 forward, all Privigen shipped to these countries will be manufactured with the Ig IsoLo step. As regulatory approval is obtained in additional countries, the IAC step will be integrated globally.
Privigen is the first and only 10 percent, ready to use, room-temperature stored, liquid IVIG stabilized with proline, a naturally occurring amino-acid. In the United States, it is used as replacement therapy for patients with primary immunodeficiencies, and as an immunomodulatory therapy for patients with chronic immune thrombocytopenic purpura (ITP). It is available in over 70 countries around the world for treating these and other rare diseases.
For country specific indication information, visit:
Important Safety Information
Immune Globulin Intravenous (Human), 10% Liquid, Privigen®, is indicated as replacement therapy for patients with primary immunodeficiency (PI) associated with defects in humoral immunity, including but not limited to common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Privigen is also indicated to raise platelet counts in patients with chronic immune thrombocytopenic purpura (ITP).
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin products, including Privigen. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of human immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products that contain sucrose. Privigen does not contain sucrose.
- For patients at risk of thrombosis, renal dysfunction or renal failure, administer Privigen at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
See full prescribing information for complete boxed warning.
Privigen is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA, who have had hypersensitivity reactions. Patients with IgA deficiency and antibodies to IgA are at greater risk of severe hypersensitivity and anaphylactic reactions.
Privigen is derived from human plasma. The risk of transmission of infectious agents cannot be completely eliminated.
For full prescribing information for Privigen, including the boxed warning and the patient product information, visit http://www.privigen.com/professional/prescribing-information.aspx
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
About CSL Behring
CSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company,
CSL Limited (ASX:CSL), headquartered in Melbourne, Australia, employs more than 14,000 people with operations in more than 30 countries. For more information visit www.cslbehring.com and follow us on www.Twitter.com/CSLBehring. For more information about CSL Behring visit
www.CSLBehring.com or follow us at
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