Scalable System customizes stem cells for therapeutic use.
Press Release Summary:
GT(TM) Flow Transfection System enables accelerated and efficient transfection of any primary cell or cell line with greater than 90% cell viability following loading with range of molecules - proteins, drugs, plasmids, mRNA, miRNA, siRNA - or combinations thereof at volumes up to tens of billion cells. With processing time of under 30 min, solution enables consistent cGMP-compliant cell modification in closed-system for clinical/commercial scale manufacturing.
Original Press Release:
MaxCyte Introduces the GT(TM) Flow Transfection System for Application with Autologous and Allogeneic Stem Cell Therapies
Technology enhances biological activity (regenerative potential) of stem cells and accelerates development of proprietary enhanced therapeutics
GAITHERSBURG, Md., Feb. 17 -- MaxCyte announces today the introduction of its GT(TM) Flow Transfection System at the 4th Annual Stem Cell Summit to be held in New York, NY. The MaxCyte GT(TM) Flow Transfection System is a validated, scalable technology for customizing the biological activity of cells for therapeutic use. This system, which is supported by a US FDA Master File, enables rapid and efficient transfection of any primary cell or cell line with >90% cell viability following loading with a broad range of molecules (proteins, drugs, plasmids, mRNA, miRNA, and siRNA) or combinations thereof, at volumes up to tens of billion cells, processed in under 30 minutes. The MaxCyte GT(TM) Flow Transfection System enables consistent cGMP-compliant cell modification in a closed-system for clinical/commercial scale manufacturing. Appropriate for either cGMP facility or point-of-care use, the GT(TM) Flow Transfection System allows cost-effective delivery with both autologous and allogeneic cellular therapies, customized for enhanced efficacy.
"The MaxCyte GT(TM) Flow Transfection System addresses two of the primary challenges hindering acceleration of effective stem cell therapies. It enables design and development of stem cell products modified to allow for improved regenerative responses and permits robust, automated, cost-effective, cGMP and regulatory-compliant product manufacturing," says Dr. Madhusudan Peshwa, Executive Vice President of Cellular Therapies at MaxCyte. "Such reduction in efficacy and delivery risk in the early-stages of product development can significantly reduce cost, accelerate development, and enhance effectiveness, while providing for novel Intellectual Property around such engineered cell therapy and stem cell products."
"The GT(TM) Flow Transfection System has been validated in a marketed oncology therapy and in multiple phase I/II clinical studies in oncology and regenerative medicine applications with demonstrated ability to customize and enhance biological activity of cells and ensure robust product manufacturing," stated Mr. Douglas Doerfler, Founder, CEO and President of MaxCyte. "We are excited to make available the MaxCyte GT(TM) Flow Transfection System for clinical applications at translational medical centers and to stem cell investigators involved in the discovery and development of novel pathways that facilitate development of proprietary enhanced cellular therapies and novel efficacious small molecule drugs."
Dr. Peshwa will be delivering a technical presentation at 10:25 AM at the 4th Annual Stem Cell Summit. His presentation will provide an overview of MaxCyte's GT(TM) Flow Transfection System and will discuss specific examples of the development of engineered stem cell products that exhibit enhanced biological activity in vitro and in vivo, and will also discuss clinical experiences from ongoing human trials.
About MaxCyte
MaxCyte is the leader in providing clinical/commercial cell modification technologies and technical expertise to enable the development of proprietary enhanced cellular therapeutics to global leaders in life sciences. MaxCyte's unique transfection technology platform enables the discovery, development, manufacturing and delivery of innovative and important therapeutic products for a wide range of diseases. MaxCyte's proprietary cell loading technology provides critical enablement for cell therapeutics targeting a broad range of chronic diseases by allowing the controlled modification of cell function. By providing unparalleled consistency, scalability, and loading efficiency while avoiding the inherent drawbacks of alternative methods, the MaxCyte GT(TM) Flow Transfection System enables the development of proprietary enhanced therapies that cannot otherwise be commercialized. MaxCyte's clinical-grade cell loading technology platform is supported by an FDA Master File and well validated, with multiple products enabled by the MaxCyte technology in clinical development and on market. Building on these experiences, MaxCyte also offers the MaxCyte STX(TM) Scalable Transfection System as a product for sale to biopharmaceutical companies involved in the burgeoning area of cell-based drug screening and small molecule drug discovery.
For more information: http://www.maxcyte.com/
CONTACT: Madhusudan V. Peshwa, Ph.D., Executive Vice President, Cellular Therapies of MaxCyte, Inc., +1-301-944-1700, mvpeshwa@maxcyte.com
