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.
authors.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital , Houston, Texas, USA.
authors.forename: Pradip
authors.initials: P
authors.lastname: Bajgain
authors.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital , Houston, Texas, USA.
authors.forename: Roopa
authors.initials: R
authors.lastname: Mucharla
authors.affiliation: Wilson Wolf Manufacturing Corporation , New Brighton, Minnesota, USA.
authors.forename: John
authors.initials: J
authors.lastname: Wilson
authors.affiliation: Wilson Wolf Manufacturing Corporation , New Brighton, Minnesota, USA.
authors.forename: Dan
authors.initials: D
authors.lastname: Welch
authors.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital , Houston, Texas, USA.
authors.forename: Usanarat
authors.initials: U
authors.lastname: Anurathapan
authors.affiliation: Celgene Cellular Therapeutics, Celgene Corporation , Warren, New Jersey, USA.
authors.forename: Bitao
authors.initials: B
authors.lastname: Liang
authors.affiliation: Celgene Cellular Therapeutics, Celgene Corporation , Warren, New Jersey, USA.
authors.forename: Xiaohua
authors.initials: X
authors.lastname: Lu
authors.affiliation: University of Wisconsin-Madison, Waisman Biomanufacturing , Madison, Wisconsin, USA.
authors.forename: Kyle
authors.initials: K
authors.lastname: Ripple
authors.affiliation: University of Wisconsin-Madison, Waisman Biomanufacturing , Madison, Wisconsin, USA.
authors.forename: John M
authors.initials: JM
authors.lastname: Centanni
authors.affiliation: Center for Applied Technology Development, Beckman Research Institute of City of Hope , Duarte, California, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Hall
authors.affiliation: Center for Applied Technology Development, Beckman Research Institute of City of Hope , Duarte, California, USA.
authors.forename: David
authors.initials: D
authors.lastname: Hsu
authors.affiliation: Center for Applied Technology Development, Beckman Research Institute of City of Hope , Duarte, California, USA.
authors.forename: Larry A
authors.initials: LA
authors.lastname: Couture
authors.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital , Houston, Texas, USA.
authors.forename: Shubhranshu
authors.initials: S
authors.lastname: Gupta
authors.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital , Houston, Texas, USA.
authors.forename: Adrian P
authors.initials: AP
authors.lastname: Gee
authors.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital , Houston, Texas, USA.
authors.forename: Helen E
authors.initials: HE
authors.lastname: Heslop
authors.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital , Houston, Texas, USA.
authors.forename: Ann M
authors.initials: AM
authors.lastname: Leen
authors.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital , Houston, Texas, USA.
authors.forename: Cliona M
authors.initials: CM
authors.lastname: Rooney
authors.affiliation: Center for Cell and Gene Therapy, Baylor College of Medicine, Houston Methodist Hospital, Texas Children's Hospital , Houston, Texas, USA.
authors.forename: Juan F
authors.initials: JF
authors.lastname: Vera