Immune globulin subcutaneous, human 20% solution (Xembify(R)), a new high concentration immunoglobulin product for subcutaneous administration

Authors: Alonso, W., Vandeberg, P., Lang, J., Yuziuk, J., Silverstein, R., Stokes, K., McBride, D., Cruz, M., Burns, D., Merritt, W. K., Willis, T., and Jorquera, J. I.

Published: Biologicals February 2020

Affiliations: Grifols Bioscience Research Group, 85 TW Alexander Drive, Research Triangle Park, NC, 27709, USA ; Grifols Therapeutics LLC, 8368 US 70 Business Hwy West, Clayton, NC, 27520, USA.

Abstract: 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%.