How is intravenous immunoglobulin (IVIG) made?
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How is intravenous immunoglobulin (IVIG)
How is intravenous immunoglobulin (IVIG) made? Intravenous immunoglobulin (IVIG) is a crucial therapeutic product derived from pooled human plasma, sourced from volunteer blood donors at licensed centers. The manufacturing process commences with plasma pooling, combining donations from numerous individuals to form large batches. Following fractionation, which separates immunoglobulins from other plasma components, rigorous purification ensues to eliminate contaminants and inactive proteins. To bolster safety, extensive virus inactivation and removal methods, including solvent-detergent treatment, pasteurization, and nanofiltration, are employed. These stringent procedures significantly reduce the risk of infectious agent transmission, maintaining the immunoglobulin's integrity. Despite these measures, a small risk of infection transmission remains with IVIG administration. Statistical analyses reveal that the risk is remarkably low, with a reported incidence of less than 1 in 10,000 infusions. This risk is further mitigated by comprehensive testing and quality control procedures during manufacturing. Healthcare providers diligently monitor patients for signs of adverse reactions during and after IVIG infusion. While adverse events are rare, the potential risks associated with IVIG therapy underscore the importance of meticulous patient selection and ongoing vigilance in clinical practice. Nonetheless, the considerable benefits of IVIG therapy, particularly in patients with immunodeficiency disorders or autoimmune diseases, often outweigh the minimal risks, making it a vital and life-saving treatment option.
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در تاریخ 1402/12/24 منتشر شده
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