Human immunoglobulin (Ig), also known as intravenous immunoglobulin (IVIg), is a blood product extracted from donated human plasma. It contains antibodies or immunoglobulins (proteins produced by plasma cells that function as antibodies) that help fight off infections in the body. With the advances in pharmaceutical techniques, human Ig with controlled pH4 level (pH4 IVIg) has been developed which promises better stability and safety compared to conventional Ig preparations. This article discusses the uses, mechanism of action, manufacturing process, safety and efficacy of pH4 IVIg.
Uses of pH4 IVIg
pH4 IVIg has several important clinical applications where it is used as a replacement therapy. Some of its major uses include:
– Primary immunodeficiency disorders: pH4 IVIg is used as a replacement therapy for patients with congenital absence or defects in antibody production leading to recurrent infections. This includes conditions like agammaglobulinemia, common variable immunodeficiency etc.
– Autoimmune disorders: It has shown effectiveness in treating various autoimmune disorders like immune thrombocytopenia, Guillain-Barré syndrome, Kawasaki disease etc where antibodies target self-antigens.
– Neurological disorders: pH4 IVIg helps reduce symptoms and improve outcomes in some neurological disorders like chronic inflammatory demyelinating polyneuropathy.
– Other uses: It also benefits patients with bone marrow transplant, Alzheimer’s disease, chronic fatigue syndrome and as adjuvant therapy in various hematological cancers.
Mechanism of Action
The mechanism through which pH4 IVIg exerts its effects is multifaceted and not fully understood. Some proposed mechanisms include:
– Replacement of reduced antibody levels: pH4 IVIg replenishes the decreased or absent immunoglobulins in primary antibody deficiency conditions.
– Immunomodulation: It modulates the immune system through suppression of T-cell and B-cell activities, downregulation of pro-inflammatory cytokines, inhibition of complement activation and modulation of Fc receptors.
– Neutralization of pathogenic antibodies: The antibodies in pH4 IVIg bind to and neutralize autoantibodies and pathogenic antibodies involved in various disorders.
– Block autoantibody function: It forms complexes with autoantibodies rendering them inactive and preventing cell/tissue damage.
pH4 IVIg undergoes extensive fractionation from pooled human plasma donations. The steps involve:
– Plasma collection and viral inactivation: Plasma is collected from thousands of screened donors and treated with solvent/detergent to inactivate viruses.
– Fractionation: Plasma proteins are separated by Cohn cold ethanol fractionation and pH4 specific IgG fraction is collected.
– Purification: The IgG fraction undergoes additional purification using column chromatographyunder controlled pH conditions.
– Viral filtration: The purified final solution must pass through filters to remove potential viruses.
– Quality testing: Extensive safety and sterility testing is done before release.
Safety and efficacy studies
Several clinical studies have demonstrated pH4 IVIg to be safe and effective for its indications:
– Safety: It is generally well-tolerated with infrequent minor adverse effects. Advanced viral inactivation and filtering reduces potential infections risks.
– Efficacy: Controlled clinical trials found it non-inferior to standard Ig preparations in preventing infections in primary immunodeficiency and reducing relapses in autoimmune/neurological diseases.
– Stability: Its controlled pH4 formulation lends superior stability over 1-2 years compared to earlier Ig products with variable pH levels allowing for flexible administration.
– Convenience: pH4 condition make it compatible with infusion solutions and delivery via infusion pumps for outpatient/home-based treatment offering better convenience and quality of life for patients.
In conclusion, human Ig prepared at optimal pH4 level has shown safety, efficacy and clinical advantages over other Ig products used in several chronic disorders. With more robust processing and quality control, it now offers a reliable replacement therapy option for patients with humoral immune dysfunction and autoimmune conditions. Wider availability of pH4 IVIg can significantly benefit patient outcomes and healthcare.
- Source: Coherent Market Insights, Public sources, Desk research
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