Manufacturing Quality
CSL Behring has developed a highly controlled system of plasma collection, manufacturing,
and distribution to ensure that its products, including Privigen, meet high
safety and quality standards.1
Rigorous Plasma Screening Process
- Several virus inactivation/removal techniques reduce the risk of transmission
of pathogens
- Privigen is prepared from plasma obtained from US donors for US product distribution,
using rigorous donor screening procedures
- Each unit of plasma is screened for markers of infection: anti-HIV-1/2 and anti-HCV
antibodies and hepatitis B surface antigen (HBsAg)
- Plasma is tested for HIV, HCV, HBV, and B19 genome by nucleic acid testing
- The final manufacturing plasma pool is again tested for anti-HIV-1/2 and HBsAg and
for HIV, HCV, and HBV genome by nucleic acid testing
Each step has been carefully investigated and validated using appropriate models.1
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Manufacturing Process Including 3 Virus Inactivation and Removal Steps1
- Privigen is prepared from large pools of human plasma by a combination of cold ethanol
fractionation, octanoic acid fractionation, and anion exchange chromatography.
- During production, potential contamination is minimized by three complementary methods
that target a broad range of pathogens, including enveloped and non-enveloped viruses;
- Virus inactivation by pH 4 incubation
- Depth filtration, a partitioning process that contributes to the overall virus reduction
capacity
- Nanofiltration capable of removing viruses as small as 20 nm
-
Validated TSE removal steps, including octanoic acid fractionation, depth filtration, and virus filtration
Each step has been carefully investigated and validated using appropriate models.1
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A Heritage of Safety
CSL Behring has been fractionating human plasma for more than 65 years, employing
an expert team of virologists and quality assurance systems and controls that are
among the most rigorous and powerful in the industry.
CSL Behring is certified by :
-
QSEAL (Quality Standards of Excellence, Assurance, and Leadership)
-
International Quality Plasma Program
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Related Links
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Important Safety Information
Immune Globulin Intravenous (Human), 10% Liquid, Privigen® is indicated for the treatment of 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 rapidly raise platelet counts to prevent bleeding in patients with chronic immune thrombocytopenic purpura (ITP).
WARNING: Renal dysfunction, acute renal failure, osmotic nephrosis, and death may be associated with the administration of Immune Globulin Intravenous (Human) (IVIg) products in predisposed patients. Administer IVIg products at the minimum infusion rate possible. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIg products containing sucrose. Privigen does not contain sucrose. See full prescribing information for complete boxed warning.
Privigen is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
In patients at risk for developing renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Thrombotic events have been reported with Privigen and other IVIg treatments. Monitor patients with risk factors for thrombotic events, including a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity.
Aseptic meningitis syndrome (AMS) may occur infrequently with Privigen and other IVIg treatments; AMS may occur more frequently with high doses and/or rapid infusion of IVIg. Hemolysis, hemolytic anemia, and pulmonary adverse events have also been reported. There have been reports of noncardiogenic pulmonary edema in patients administered IVIg. If transfusion-related acute lung injury is suspected, test product and patient for antineutrophil antibodies.
Privigen is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
In clinical studies, the most common adverse reactions with Privigen were headache, pain, nausea, pyrexia/hyperthermia, fatigue, and chills. Anemia was an additional common adverse reaction in patients being treated with Privigen for chronic ITP. The most serious adverse reactions in chronic ITP patients were aseptic meningitis syndrome in one subject and hemolysis in eight subjects.
For more information about Privigen, please see full Prescribing Information.
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.