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For Cell and Gene Modified Cell Therapy (CGT) manufacturing, a robust contamination control strategy (CCS) is necessary to ensure compliance with current Good Manufacturing Practices (cGMP). A successful CCS helps ensure safety, purity, efficacy, and quality of a CGT product. CGT manufacturers should implement Closed Systems wherever possible and employ equipment that maintains a stable, clean environment with advanced monitoring. We show that Closed System G-Rex® bioreactors combined with Thermo ScientificTM HeracellTM ViosTM CR carbon dioxide (CO2) incubators enable simplified parallel processing capabilities and significantly reduced contamination risks in a highly efficient production.

To better optimize their manufacturing process for a current clinical trial and IND amendment, AgonOx and Providence began to look for products to close and streamline key portions of the established manufacturing process for a shared project. It was imperative to find products that would maintain established levels of cell recovery, viability, and efficacy.

Current methods of final formulation fill and finish either require manual processing which has the potential to result in operator error, or utilized automated systems with limited capabilities. Manual methods or semi-automated systems may present the risk of increased exposure time of cells to DMSO within the cryoprotectant, causing a reduction in post-thaw viability and recovery. The Cue Cell Processing System is a functionally closed and fully automated instrument with enhanced system functionalities for F/F/F of Cell and Gene therapy products

TcBuster-MTM (TcB-MTM) is a commercially available non-viral transposase-based editing platform that overcomes current viral limitations. TcBuster is found in the red flour beetle and is a member of the hAT family of transposases. Using directed evolution, we engineered a hyperactive mutant (TcB-M) that has improved transposition rates using less mRNA transposase and NanoplasmidTM DNA transposon.

Current iNK differentiation protocols typically utilize xenogenic feeder cells, which could be problematic for patient safety, or they lack robustness and are highly variable in differentiation efficiency. Using animal-free small molecules and recombinant proteins, Bio-Techne developed a feeder-free differentiation process to reliably generate iNKs at scale by optimizing for CD34+ hematopoietic stem cells (iHSC) prior to downstream NK differentiation.

This scientific poster presented at CIMT 2023 investigates glioblastoma, a WHO grade IV glioma and the most common primary adult brain tumor, and the expression of elevated levels of HLA-E that block NK cells with expression of the inhibitory NKG2A receptor, aiming to establish a large-scale ex vivo expansion of functional NKG2C+ NK cells.  Doing so from peripheral blood employing bottom-gas permeable membrane bioreactors (G-Rex) and using a recently developed PC-3 feeder cell line genetically engineered with IL-2, membrane-bound IL-15, as well as a first generation single chain trimeric HLA-E molecule.

This scientific poster investigates the kinetics of human T cell expansion in small scale G-Rex6M bioreactors using ScaleReady reagents. Data show the affect of seeding density on fold expansion, total cell yield, and phenotypic phenotypic composition of expanded T cells, including total and memory CD4⁺ and CD8⁺ cells.