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 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: Use of Immune Globulin Intravenous (IVIg) products, particularly those containing sucrose, have been associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death. Privigen does not contain sucrose. Administer Privigen at minimum rate practicable in patients at risk of renal dysfunction or acute renal failure. At-risk patients include those with preexisting renal insufficiency, diabetes mellitus, volume depletion, sepsis, or paraproteinemia; over 65 years of age; or receiving known nephrotoxic drugs. 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 and history of hypersensitivity.
Monitor patient vital signs throughout infusion of Privigen. In cases of severe hypersensitivity or anaphylactic reactions, discontinue administration and institute appropriate medical treatment. In patients at risk for developing renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Also monitor patients with risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.
Patients could experience increased serum viscosity, hyperproteinemia or hyponatremia; infrequently, aseptic meningitis syndrome (AMS) may occur (most often with high doses and/or rapid IVIg infusion). There have been reports of IVIg-related hemolysis, hemolytic anemia, and pulmonary adverse events, including transfusion-related acute lung injury (TRALI). Avoid high-dose regimen where fluid volume is of concern.
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 of patients being treated with Privigen for PI, the most serious adverse reaction was hypersensitivity (one subject). Adverse reactions observed in >5% of subjects with PI were headache, pain, nausea, fatigue, chills, vomiting, joint swelling/effusion, pyrexia, and urticaria.
In clinical studies of patients being treated with Privigen for chronic ITP, the most serious adverse reactions were AMS (one subject) and hemolysis (eight subjects). Adverse reactions seen in >5% of subjects with chronic ITP were headache, pyrexia/hyperthermia, positive DAT, anemia, vomiting, nausea, increases in conjugated and unconjugated bilirubin, hyperbilirubinemia, and increased blood lactate dehydrogenase.
Treatment with Privigen might interfere with a patient's response to live virus vaccines and could lead to misinterpretation of serologic testing.
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.