Immune globulin subcutaneous, human 20% solution (IGSC-C 20%, Xembify®)—a new 20% immunoglobulin (IgG) liquid product for subcutaneous (SC) administration—has been developed by Grifols. The IGSC-C 20% formulation is based on knowledge acquired from the formulation of Immune Globulin Injection (Human),10% Caprylate/Chromatography Purified (IGIV-C 10%, Gamunex®-C). The protein concentration was increased from 10% to 20% to provide a smaller volume for SC administration. The IGSC-C 20% manufacturing process employs the same caprylate/chromatography purification steps as IGIV-C 10%, with the addition of an ultrafiltration step so that the product can be formulated at a higher protein concentration. IGSC-C 20% has been produced at full industrial scale to support clinical studies and licensure. These batches were characterized using a comprehensive panel of analytical testing. The new IGSC-C 20% product maintains the same composition, neutralizing activity, purity, and quality characteristics found in IGIV-C 10%.

Grifols已开发出一种免疫球蛋白皮下人用20％溶液（IGSC-C 20％，Xembify®），一种用于皮下（SC）给药的20％免疫球蛋白（IgG）新型液体产品。IGSC-C 20％制剂基于从免疫球蛋白注射液（人类），10％辛酸酯/色谱纯化（IGIV-C 10％，Gamunex®-C）的制剂中获得的知识。蛋白质浓度从10％增加到20％，以提供较小的体积用于SC给药。IGSC-C 20％的生产工艺采用与IGIV-C 10％相同的辛酸酯/色谱纯化步骤，并增加了超滤步骤，因此可以更高的蛋白质浓度配制产品。IGSC-C 20％已在全工业规模生产，以支持临床研究和许可。使用全面的分析测试小组对这些批次进行了表征。新的IGSC-C 20％产品保持与IGIV-C 10％相同的组成，中和活性，纯度和质量特征。