Technology Overview

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, MaxCyte enables the development of therapies not otherwise commercializable. MaxCyte's clinical-grade cell loading technology is fully developed and well validated, with an FDA Master File in place, RAC cleared, two Ph IIa trials on-going and additional programs headed for the clinic. MaxCyte is actively advancing a broad pipeline of partnered programs, as well as its own novel therapeutic candidates for out licensing, with a business model that efficiently uses capital, a strong leadership team and industry leading partners.

The MaxCyte Advantage

  • A cGMP-compliant scalable therapeutic system
  • A closed, controlled sterile system
  • Avoidance of regulatory obstacles associated with current chemical transfection and viral vector technologies
  • Increased throughput, cell-loading efficiency and viability without additional optimization
  • Access to proven technology and authorization to reference FDA Master (CBER), cGMP protocol development, cell handling and optimization expertise

While the company's basic technology is mature and stable, considerable energy is devoted to R&D on applications and on refinements pertinent to such applications. MaxCyte has active collaborations and R&D agreements with academic centers and corporations across the spectrum of cell-based therapies. The examples of such collaborations, listed below, illustrate the scope of this activity:

  • Immunotherapy for Chronic Lymphocytic Leukemia (CLL) with Autologous Tumor Cells engineered to express hCD40L- and hIL-2 - currently in Phase IIa (with Malcolm Brenner, Center for Cell and Gene Therapy, Baylor).
  • Engineered Endothelial Progenitor cells for the treatment of Pulmonary Arterial Hypertension, currently in Phase IIa (with Duncan Stewart, University of Toronto, and United Therapeutics)
  • Development of a Rapid, Closed, Large-Scale Cell Loading Process for the Manufacture of Telomerase mRNA-Transfected Dendritic Cell Cancer Vaccine (with Geron Corporation)
  • Development of Immunotherapeutics for Mantle Cell Lymphoma (with Ron Levy, Stanford).
  • Large-scale production of lentiviral vectors using adherent and suspension-adapted cells (MaxCyte development, funded by an NIH SBIR grant).

Electroporation is routinely used in research laboratories for the transfection of eukaryotic and prokaryotic cells. Existing electroporation technology is limited by its ability to treat only small suspensions of cells (usually < 1 mL) in non clinical applications. For the technology to be clinically relevant, it must be capable of subjecting larger volumes of cells to the electroporation process, and it must do this in a closed, sterile system with high efficiency and cell viability such that it can be integrated into cGMP production standards. In addition, the pulsed electric fields must be applied with great precision, and the materials and procedures for pre- and post-electroporation cell processing must be carefully chosen and adapted for each application.

MaxCyte has developed a clinically oriented cell loading capability applicable to a wide variety of human cells, which combines speed, safety and precision. The cell loading technology uses flow electroporation to overcome the limitation of sample size with proprietary software and specially designed high performance electronics to deliver a precise pulsed electric field. The MaxCyte system can process volumes ranging from 0.02 mL to >1 L, with broad cell concentrations, in less than 30 minutes. Transgenes for markers (eGFP) and functional proteins (e.g., cytokines, angiogenic factors) have been loaded in plasmids up to 14 kb in size. The system is capable of loading a variety of molecules including: DNA plasmids, mRNA, siRNA, proteins, total cell lysates, antibodies and minichromosomes.