Notable Quotes:

“CIK cells expanded in G-Rex (CIK-Gs) are phenotypically very similar to those expanded in T-flasks for expression of a quite extensive panel of activation, differentiation and inhibitory molecules and showed a similar T cell subset composition (CD4, CD8, TH1, TH2, TH17, Treg, αβ and γδ as well as naïve/memory subsets). CIK-Gs are functional in vitro (strong cytotoxic activity against K562 and REH leukemia targets) and in vivo (therapeutic activity in the CD19+ orthotopic pre-B acute leukemia model ALL-2) and do not induce GvHD."

“In the context of clinical trials involving treatments with cell products dedicated to single, severely ill patients, speed of production and release of ATMPs are crucial elements for the success of therapy. A more efficient and rapid expansion was demonstrated for CIKs (either from PB or CB) cultured in G-Rex in comparison with T-flasks (9.7 days and 21 days, respectively). Similarly, Blinatumomab-Expanded T cells cultured in G-Rex (BET-Gs) were obtained in a mean of 10.8 days in G-Rex with less variability of final yields of CD3+ cells compared to BETs expanded in T-flasks and a similar composition of T cell subsets was demonstrated."

“Conditions set up to expand CIKs or BETs in the small vessels (G-Rex10M single vessels or G-Rex6M multi-well vessels) can be scaled up to the G-Rex100M vessels, just applying the same plating density and using medium and additives in proportion to total volume. The constant proportion between gas-permeable surface area and maximal volume of culture medium means that the scale-up is straightforward and reproducible."

“The G-Rex vessels are different from the rocking motion, hollow fiber, stirred vessels or Prodigy systems in that they are disposable, single-use culture vessels that can easily be implemented at low cost. Several vessels can be inserted in a single standard incubator, potentially allowing parallel expansions of multiple products with just one instrument. In contrast, other platforms require specific and quite expensive bioreactors in addition to single-use culture bags or vessels, and the machinery generally needs to be multiplied to be able to perform more than one expansion run in parallel. This of course increases the costs significantly."

“CIKs and BETs can be conveniently and safely expanded in G-Rex devices for clinical purposes. The method to expand CIK-Gs from healthy donors and BET-Gs from B-NHL patient PB was validated in GMP; all product attributes (including cytotoxic potential, endotoxin contamination, sterility, and mycoplasma) were compliant with the specifications. The lower risk of microbial contamination during culture using G-Rex, thanks to the reduced manipulation, facilitate early release of products in case of urgent clinical need before full quality control data have been obtained."

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.”

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.”

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.

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”

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”

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.”