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Hypertonic albumin refers to concentrated solutions of human serum albumin, typically at concentrations of 20% or 25%, which exert significantly higher colloid osmotic pressure than standard 5% (iso-oncotic) solutions. These formulations are primarily used for rapid plasma volume expansion, the management of severe hypoalbuminemia, and the reduction of edema in conditions such as cirrhosis or nephrotic syndrome. KM Biologics is developing a specific hypertonic albumin replacement fluid, identified by the code Alb-PE-01, for use in plasma exchange (PE) therapy. This product is being investigated as a replacement fluid in patients with autoimmune and neurological conditions, including myasthenia gravis, systemic lupus erythematosus, and chronic inflammatory demyelinating polyneuropathy, to evaluate its safety profile and its ability to maintain oncotic pressure and protein levels during the exchange process.
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