Immune globulin subcutaneous, human 20% solution (Xembify®), a new high concentration immunoglobulin product for subcutaneous administration
| Autor: | John Lang, Todd Willis, Doug Burns, Juan I. Jorquera, Pete Vandeberg, Kenya Stokes, Rebecca Silverstein, William Alonso, Jeffrey A. Yuziuk, W. Keither Merritt, Maria Cruz, Dennis McBride |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Injections Subcutaneous Ultrafiltration Bioengineering Applied Microbiology and Biotechnology Liquid product 03 medical and health sciences 0302 clinical medicine Humans 030212 general & internal medicine Quality characteristics Pharmacology High concentration Chromatography General Immunology and Microbiology biology Chemistry Manufacturing process Industrial scale General Medicine 030104 developmental biology Immunoglobulin G biology.protein Antibody Protein concentration Biotechnology |
| Zdroj: | Biologicals : journal of the International Association of Biological Standardization. 64 |
| ISSN: | 1095-8320 |
| Popis: | 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%. |
| Databáze: | OpenAIRE |
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