Demonstrates an established closed CAR-T cell therapy Platform (A G-Rex centered manufacturing platform)
Innovative Development of Closed CAR T Platform (Poster)
Authors: Gil Joseph, et al
Publication: WuXi Advanced Therapies
Published Date : 1/1/2020
Notable Quotes:

“Showed sufficient transduction efficiency (day7) with low MOI in scaled down model for transduction in G-Rex”

“The platform includes pre-evaluated and qualified equipment, technologies, and materials with developed closed unit operations. “

“To enable swift onboarding of the customer process through manufacturing, WuXi has established template batch records, bill of materials, standardized testing catalog, and specifications for cGMP materials.”
CAR-T-Demonstrates how the G-Rex can perform activation, transduction and expansion all in one single disposable device.
Streamlined production of genetically modified T cells with activation, transduction and expansion in closed-system G-Rex bioreactors
Authors: Christine Gagliardi, et al
Publication: Cytotherapy
Published Date : 10/16/2019
Notable Quotes:

“This study demonstrates that T cells can be transduced with retroviral vectors in solution in the G-Rex bioreactor with addition of Vectofusin-1 as a transduction enhancer. The simplified transduction step allows for an entire process, from activation to harvest, to be carried out in a single vessel. “

“Clinically relevant levels of transgene expression and cell numbers can be achieved by combining reagents in the GRex, without complicated time-consuming coating steps of traditional transduction.”

First publication detailing transduction taking place in G-Rex. Additionally, they compared the All-In-One G-Rex process to the traditional method of CAR T production in gas permeable bags. “Further, the G-Rex based process reduced the cost of materials by 38% and hand-on time by 75% to generate a batch of 1.4x10e9 transgenic cells.” There is an excellent table displaying the cost reduction and labor savings.
Provides details on using G-Rex for an efficient approach to generate highly functional Vγ9Vδ2 T cells in massive numbers suitable for clinical application in an allogeneic setting.
Large-scale expansion ofVγ9Vδ2T cells with engineered K562 feeder cells in G-Rex vessels and their use as chimeric antigen receptor– modified effector cells
Authors: Lin Xiao, et al
Publication: Cytotherapy
Published Date : 12/17/2017
Notable Quotes:

“optimized the co-culture ratio of K562 aAPCs to immune cells, and migrated this method to a G-Rex cell growth platform to derive clinically relevant cell numbers in a Good Manufacturing Practice (GMP)-compliant manner”
Comparison of TIL production in traditional method (Flask + gas permeable bag) vs G-Rex at MD Anderson. Showed TILs produced in G-Rex have a higher spare respiratory capacity and demonstrate a more oxidative phenotype than the traditional method.
The beneficial effects of a gas-permeable flask for expansion of Tumor-Infiltrating lymphocytes as reflected in their mitochondrial function and respiration capacity
Authors: Marie-Andrée Forget, et al
Publication: OncoImmunology
Published Date : 3/2/2016
Notable Quotes:

“High spare respiratory capacity is believed to be a feature of memory T cells that imparts them with better in vivo persistence, as opposed to effector T cells. We are thus postulating that the high spare respiratory capacity and the high OCR that we observed in TIL grown in high oxygen environment, more specifically the CD8+ BTLA+ cells, could therefore result in enhanced survival and persistence after transfer, which could confer better tumor control.”

“The G-Rex could favor expansion of less-differentiated cell subsets likely due to the availability of oxygen. High spare respiratory capacity is believed to be a feature of memory T-Cells"

“We also observed and reported that the use of the new flask impacted the phenotype of post expansion CD8C T cells, which had a consistently higher expression of a molecule previously associated with clinical response in our clinical trial”

“All together, the metabolic phenotype of melanoma TIL propagated in G-Rex was consistently more oxidative”
Provides a comprehensive overview of the underlying principles that make G-Rex M the most efficient and versatile style of G-Rex device.
Optimizing the production of suspension cells using the G-Rex “M” series
Authors: Pradip Bajgain, et al
Publication: Molecular Therapy — Methods & Clinical Development
Published Date : 11/1/2014
Notable Quotes:

“the use of this device actually decreases the number of cell divisions required to achieve a given target cell number.”

“These results suggest that cell numbers can be calculated accurately by simply measuring glucose in cell culture supernatant.”

“The G-Rex can operate as either an open or closed system. In order to harvest the cells expanded in the closed system G-Rex without exposing the culture to the environment, Wilson Wolf developed the “GatheRex,” a semiautomated system that allows the operator to drain the excess media present in the culture and collect cells without risk of contamination.”