G-Rex® Product Documentation
Review of a serum-free method of ex vivo CIK cell expansion based on the use of G-Rex static bioreactors, which drastically reduces culture manipulations and can be easily reproduced under GMP conditions as well as scaled for larger cell numbers.
A serum-free protocol for the ex vivo expansion of Cytokine-Induced Killer cells using gas-permeable static culture flasks
Authors: Palmerini, et al
Publication: Cytotherapy
Published Date : 9/1/2020
Notable Quotes:
“G-Rex led to large numbers of CIK cells, with a minimal need for technical interventions, thus reducing the time and costs of culture manipulation....The described procedure can be easily translated to large-scale production under Good Manufacturing Practice.”
“Thus, the higher proportion of naïve and central memory CD3+CD56-T cells in the final CIK cell product, which we demonstrate to occur in the G-Rex cultures, could ensure a source of new post-infusion CIK effector cells that may possibly contribute to higher survival rates and long-term clinical responses.”
“G-Rex led to large numbers of CIK cells, with a minimal need for technical interventions, thus reducing the time and costs of culture manipulation....The described procedure can be easily translated to large-scale production under Good Manufacturing Practice.”
“Thus, the higher proportion of naïve and central memory CD3+CD56-T cells in the final CIK cell product, which we demonstrate to occur in the G-Rex cultures, could ensure a source of new post-infusion CIK effector cells that may possibly contribute to higher survival rates and long-term clinical responses.”
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.”
“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.
“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”
“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”
“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.”
“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.”