Knowledge HQ

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® 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.

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.

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.