- Charles River generated best-in-class data with Kytopen's
Flowfect™ technology in comparative study.
- The study using CRISPR/Cas9 TRAC gene knockout experiments in
primary T cells revealed that the Flowfect Tx™ platform delivers
greater cell viability and editing efficiency compared to
conventional, commercially available electroporation
platforms.
- Kytopen's Flowfect™ technology will accelerate the development
and manufacture of the highest quality advanced cell therapies with
its easy-to-implement cellular engineering platform.
CAMBRIDGE, Mass., Sept. 17,
2024 /PRNewswire/ -- 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 adding 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.
About Kytopen
Kytopen, headquartered in Cambridge, Massachusetts with an R&D site
in Denver, Colorado, is a leading
biotechnology company specializing in the development and
commercialization of non-viral continuous flow cellular engineering
platforms to accelerate the processes of discovery, development,
and the manufacture of advanced engineered cell therapies In
2023, Kytopen unveiled the Flowfect Discover™ 96-well platform, an
automated high-throughput system for the optimization of genome
engineering, and disclosed strategic partnerships with
industry-leading contract development and manufacturing
organizations (CDMOs) and cell therapy-focused medical centers. By
combining the Flowfect Discover™ platform with the large-scale
manufacturing Flowfect Tx™ system in process development workflows,
cell therapy developers overcome manufacturing challenges,
fostering swifter and more cost-effective innovation.
https://www.kytopen.com/
Investor Contact:
Michael Chiu PhD., CEO
mchiu@kytopen.com
Business and Corporate Development Contact:
Kevin Gutshall, CCO
kgutshall@kytopen.com
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SOURCE Kytopen