期刊
BIOLOGICALS
卷 64, 期 -, 页码 34-40出版社
ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
DOI: 10.1016/j.biologicals.2020.01.004
关键词
SCIG 20% liquid; Subcutaneous immunoglobulin; SCIG replacement therapy; Intravenous immunoglobulin; IVIG
资金
- Grifols Bioscience Research Group from the Bioscience Industrial Group (Grifols), Research Triangle Park, NC, USA
Immune globulin subcutaneous, human 20% solution (IGSC-C 20%, Xembify (R))-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 (R)-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%.
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