@article{a548f45041cc41af9a107912e8c8252c,
title = "Optimizing the production of suspension cells using the G-Rex M series",
abstract = "Broader implementation of cell-based therapies has been hindered by the logistics associated with the expansion of clinically relevant cell numbers ex vivo. To overcome this limitation, Wilson Wolf Manufacturing developed the G-Rex, a cell culture flask with a gas-permeable membrane at the base that supports large media volumes without compromising gas exchange. Although this culture platform has recently gained traction with the scientific community due to its superior performance when compared with traditional culture systems, the limits of this technology have yet to be explored. In this study, we investigated multiple variables including optimal seeding density and media volume, as well as maximum cell output per unit of surface area. Additionally, we have identified a novel means of estimating culture growth kinetics. All of these parameters were subsequently integrated into a novel G-Rex M series, which can accommodate these optimal conditions. A multicenter study confirmed that this fully optimized cell culture system can reliably produce a 100-fold cell expansion in only 10 days using 1L of medium. The G-Rex M series is linearly scalable and adaptable as a closed system, allowing an easy translation of preclinical protocols into the good manufacturing practice.",
author = "Pradip Bajgain and Roopa Mucharla and John Wilson and Dan Welch and Usanarat Anurathapan and Bitao Liang and Xiaohua Lu and Kyle Ripple and Centanni, {John M.} and Christine Hall and David Hsu and Couture, {Larry A.} and Shubhranshu Gupta and Gee, {Adrian P.} and Heslop, {Helen E.} and Leen, {Ann M.} and Rooney, {Cliona M.} and Vera, {Juan F.}",
note = "Funding Information: This work was supported in part by the Production Assistance for Cellular Therapies (PACT) program (NHLBI contract #HHSN268201000007C), P01CA094237 and CA094237 from the NIH and a SCOR award from the Leukemia and Lymphoma Society. We also appreciate the support of the Adrienne Helis Malvin Medical Research Foundation through its direct engagement in the continuous active conduct of medical research in conjunction with Baylor College of Medicine. J.F.V. is supported by an Idea Development Award from the Department of Defense Prostate Cancer Research Program (no. W81XWH-11-1-0625). Finally, we appreciate the shared resources provided by the Dan L Duncan Cancer Center support grant P30CA125123. Funding Information: Present research in Center for Cell and Gene Therapy receives support from Celgene Corporation, of which authors B.L. and X.L. are employees, but the current work was not supported by Celgene. J.W. and D.W. are employees, and J.F.V. is a scientific advisor for Wilson Wolf Manufacturing, which partially supported this work by providing some G-Rex prototypes and reagents. J.W., D.W., and J.F.V. have joint patents on the G-Rex technology. Publisher Copyright: {\textcopyright} 2014 The American Society of Gene & Cell Therapy. Copyright: Copyright 2018 Elsevier B.V., All rights reserved.",
year = "2014",
month = jan,
day = "8",
doi = "10.1038/mtm.2014.15",
language = "English (US)",
volume = "1",
pages = "14015",
journal = "Molecular Therapy - Methods and Clinical Development",
issn = "2329-0501",
publisher = "Nature Publishing Group",
}