Kytopen Corp., a leader in providing non-viral, continuous flow cellular engineering technologies, today announced the completion of a 10-day study conducted by the Charles River International, Inc. (Charles River), a highly respected, global provider of drug discovery and non-clinical development solutions, comparing Kytopen’s Flowfect Tx™ GMP-ready, clinical- and manufacturing-scale, cellular engineering platform with two conventional, commercially available electroporation platforms. A key finding in this study was the considerably higher yields of gene-edited, viable cells at multiple timepoints with the Flowfect Tx™ platform that have the potential to be used as the final drug substance. These results confirm that Kytopen is prepared to accelerate the development and manufacture of cell therapies with its easy-to-implement cellular engineering platform to yield the highest quality advanced cellular therapies.
A highly tunable system, Flowfect™ technology is unique in that it combines mechanical, electrical, and chemical forces, and allows the adjustment of multiple parameters to maximize transfection efficiency, cell health, and cell yield. An additional key differentiator is that the Flowfect Tx™ platform is not restricted to the batch processing of conventional electroporators that can overheat and harm cells. It is designed with continuous flow processing, enabling the editing of hundreds of billions of cells in just minutes to scale from clinical to GMP manufacturing in a closed, automated system.
“Flowfect™ technology utilizes the benefits of electroporation while eliminating the drawbacks by combining mechanical and chemical forces to lower the overall voltage requirements, allowing for a gentler treatment of cells,” said Alex Sargent, Director, Process Development, Cell Therapy CDMO Services at Charles River. “Scale up and ease of use are important factors in optimizing cell therapy manufacturing. For this study, we simply plugged in the instrument, added cells and payload, and ran a single protocol without any protocol or reagent changes or optimization. It truly is just plug and play.”
“This is a milestone for Kytopen as many cell therapies are developed and manufactured by CDMOs and we are excited to present this data from such a prestigious CDMO as Charles River,” said Kevin Gutshall, Chief Commercial Officer at Kytopen. “We have a GMP-scale manufacturing platform that has already been evaluated for tech transfer and this study further highlights the ease of implementation to develop superior yields of final drug substance.”
To access a summary of the study results, visit Making Gains in Non-Viral Engineering of T Cells for Cell Manufacturing.