Cambridge-based Kytopen Corp. is establishing itself as a pivotal player in cell therapy manufacturing through two strategic partnerships announced this spring. The company's Flowfect® technology, which enables non-viral, continuous flow cellular engineering, is being combined with complementary technologies from Aldevron and Bio-Techne to create more efficient, scalable workflows for producing engineered cells for therapeutic applications.
Kytopen-Aldevron Collaboration Enhances CRISPR-Mediated T-Cell Engineering
On April 29, Kytopen and Aldevron announced a joint marketing agreement focused on combining Aldevron's Nanoplasmid™ vector technology with Kytopen's Flowfect Tx™ GMP cellular engineering platform. This collaboration aims to provide cell therapy manufacturers with an optimized workflow for CRISPR-mediated engineering of primary T cells.
The partnership leverages the strengths of both technologies: Aldevron's Nanoplasmid™ vectors offer high transgene expression with an improved safety profile, while Kytopen's Flowfect® continuous flow technology provides gentle gene delivery with unlimited scalability. Together, they create a process that yields higher quantities of healthier engineered cells compared to traditional viral and electroporation methods.
"The work with Aldevron is part of a larger, shared commitment to enable advanced cell therapies by streamlining workflows to deliver greater yields of healthier cells," said Kevin Gutshall, Chief Commercial Officer at Kytopen. "The combination of our technologies provides a GMP process for delivering high-quality CAR-T cells that is now available for use in clinical and commercial applications."
Anu Codaty, VP of Global Marketing and Strategy for Aldevron, emphasized the performance advantages: "The combination of the Nanoplasmid technology with Kytopen's Flowfect® cell engineering technology has delivered higher edited-cell yields faster, which will help meet the growing patient demand as the adoption of CRISPR-based therapies accelerates."
Bio-Techne Partnership Creates Integrated Workflow for Immune Cell Therapies
Building on its collaborative momentum, Kytopen announced a second partnership with Bio-Techne Corporation on May 8. This collaboration integrates Bio-Techne's TcBuster™ GMP non-viral genome engineering system with Kytopen's Flowfect Tx™ platform to create a streamlined workflow for developing and manufacturing advanced cell therapies.
The TcBuster™ system provides a fast, scalable method for integrating large, multigene cargos with high editing efficiency in a single vector. When combined with Flowfect® technology, which can process billions of cells in minutes, the result is a non-viral gene-editing workflow that achieves high insertion efficiencies while maintaining cell viability.
"Together our technologies offer a non-viral, gene-editing platform suitable for a range of immune cell types, in particular non-dividing cells and those sensitive to apoptosis, that will enable developers to bring more effective, advanced cell therapies to market quicker," noted Gutshall.
Technical Advantages Over Traditional Methods
Both partnerships highlight significant technical advantages over conventional cell engineering approaches. The Flowfect® technology stands out for its ability to combine mechanical, electrical, and chemical forces in a highly tunable system. This allows for optimization of multiple parameters to maximize transfection efficiency, cell health, and yield.
A key differentiator is the scale and speed of the process. Kytopen's platform can deliver hundreds of billions of engineered cells in minutes – significantly faster than other available technologies. This addresses one of the major bottlenecks in cell therapy manufacturing: producing sufficient quantities of high-quality engineered cells in a timely manner.
The non-viral approach also offers safety advantages over viral vector-based methods, potentially reducing regulatory hurdles and manufacturing complexities. For cell therapy developers, this could translate to faster development timelines and reduced costs.
Data Presentation at ISCT Annual Meeting
Both collaborations will present their data at the International Society of Cell & Gene Therapy (ISCT) Annual Meeting, taking place May 7-10, 2025, in New Orleans. Kytopen will showcase the results in a poster presentation titled "CONTINUOUS FLOW TRANSFECTION WITH FLOWFECT® TECHNOLOGY AS AN EFFICIENT, NON-VIRAL TECHNOLOGY FOR SCALABLE CRISPR-MEDIATED ENGINEERING OF PRIMARY T CELLS" on May 7.
Additionally, Kytopen will deliver a Global Showcase presentation on May 8 titled "A FULLY VALIDATED, NON-VIRAL GMP PLATFORM FOR THE MANUFACTURE OF ENGINEERED CELLS AT CLINICAL AND COMMERCIAL SCALE."
Industry Impact and Future Outlook
These partnerships represent a significant advancement in cell therapy manufacturing technology at a critical time for the industry. As cell therapies move from experimental treatments to approved therapies, manufacturing scalability and efficiency become increasingly important factors in determining which approaches will succeed commercially.
Michael Chiu, PhD, CEO of Kytopen, has positioned the company as an enabling technology provider, focused on partnerships that can accelerate the development of life-saving cell therapies. The company's recent collaborations with industry leaders like Aldevron, a Danaher Corporation company, and Bio-Techne, a global life sciences company with approximately $1.2 billion in annual sales, validate this approach.
As cell therapy applications expand beyond oncology into autoimmune diseases and other therapeutic areas, technologies that can reliably produce large quantities of precisely engineered cells will be essential for meeting patient demand. Kytopen's partnerships with Aldevron and Bio-Techne represent important steps toward addressing this challenge, potentially helping to bring more advanced cell therapies to patients more quickly and cost-effectively.
