- Kytopen announces the first implementation of its
GMP-compliant Flowfect Tx™ cellular engineering platform.
- GMP Manufacturing of non-viral engineered cells at clinical
and commercial levels has been validated externally by this
commercial partner.
- The Flowfect Tx™ technology has a Drug Master File
("DMF") on file with the U.S. Food and Drug Administration ("FDA")
in support of its use in GMP manufacturing.
- Kytopen is uniquely positioned to transform how engineered
cell therapies are manufactured by maximizing yields, delivering
hundreds of billions of engineered cells in minutes – faster
than any other technology.
CAMBRIDGE, Mass., July 16,
2024 /PRNewswire/ -- Kytopen Corp., a leader in
providing non-viral, continuous flow cellular engineering
technologies, today announced the successful sale and installation
of its Flowfect Tx™ clinical- and manufacturing-scale transfection
system to a leading, publicly traded, cell therapy company that is
pioneering the development of advanced CAR T-cell therapies. Prior
to its purchase, the undisclosed client completed an extensive
proof of concept process development with the Flowfect™ technology
as one of Kytopen's first Technology Access Program ("TAP")
partners. This clinical-stage biotechnology innovator anticipates
the submission of an investigational new drug ("IND") application
with the U.S. Food and Drug Administration ("FDA") for its lead
asset for the treatment of autoimmune diseases in the fourth
quarter of 2024.
A highly tunable system, The Flowfect™ platform 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. As a premier
TAP partner, this customer leveraged direct support from Kytopen's
specialized Field Applications Team, the Flowfect Discover™ 96-well
optimization platform, and the Flowfect Tx™ GMP-ready system to
progress from proof-of-concept testing through process development
optimization and into clinical and commercial manufacturing scale
in an accelerated program within just two weeks.
The Flowfect Tx™ system is a critical extension of the
customer's arsenal of proprietary technologies. By balancing the
influence of multiple mechanical and electrical parameters, the
Flowfect™ technology provides an optimal gene delivery process,
while continuous flow enables the processing of liters of material
to produce hundreds of billions of healthy, high-quality engineered
cells in just minutes. This addresses the primary challenges in the
manufacture of advanced cell therapies, namely the need to generate
large numbers of healthy engineered cells in a closed, automated
system.
"We are thrilled to announce the success of our partners with
the Flowfect Tx™ system as it represents an opportunity for cell
therapy developers to acquire a truly differentiated technology
that maximizes yields of edited cells." said Dr. Michael Chiu, Chief Executive Officer at
Kytopen. "We are committed to leading the way in helping the
industry accelerate development and address the challenges in the
manufacture of advanced cell therapies. This is the first of many
applications in our pipeline and we are eager to partner with
therapeutic companies worldwide."
Kytopen's Flowfect™ non-viral cellular engineering platform has
demonstrated performance across a range of cell types, payloads,
and therapeutic applications. The Company is also
collaborating with leading development partners who are using the
Flowfect™ technology for emerging therapeutic products and delivery
platforms, including extracellular vesicle ("EV")- and lipid
nanoparticle ("LNP")-based therapies.
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 continual 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/
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SOURCE Kytopen