MaxCyte Platform System

Powerful, Non-viral Cell Loading Technology

Cell loading technologies are fundamental to cell-based therapeutics, gene therapy and many biopharmaceutical manufacturing applications. Without the ability to directly modify the biological function of cells, cell therapies are severely limited. MaxCyte overcomes existing obstacles to cell therapy development with its high-volume, rapid and inherently safe technology that loads diverse cell types with nearly any molecule. The resulting cell product can then manipulate cell function; for example, delaying differentiation in stem cells, directing cells towards a desired pathway, producing a protein or eliciting/amplifying an immune response.

MaxCyte's technology is based on the principles of electroporation, which involves the application of an electric field to a cell suspension, causing the cell membrane to become transiently permeable and encouraging external material to enter the cell. MaxCyte has leveraged this fundamental property of cells -- reversible permeability in the presence of electrical charge -- to develop a unique and patent-protected technology that has been demonstrated to be simple, highly controlled and flexible. Target cells are suspended in a solution containing the construct to be loaded which, driven by eletrophoretic forces in a flow process, enters the cell where they can affect cell function. By safely and repeatedly inserting nearly any molecule, including genes, proteins, DNA or RNA, into any target cell, without the use of added biological or chemical agents, MaxCyte's technology enables the manipulation of cell function with loading efficiencies exceeding 90%. Scalable from 0.2ml to 1,000ml runs, the rapid cell processing system is closed and cGMP compliant. Data on consistency, efficiency of cell loading and cell viability is unmatched by any other method.

The Company's technical team has made significant advances in validating the technology, developing its flexibility and broad applicability and providing for robust and fully reproducible performance. Ultimately, MaxCyte was the first company to bring flow electroporation into the clinic. The cell processing system has received Master File designation with the CBER Division of the U.S. FDA and has been cleared by NIH's RAC and Health Canada. The MaxCyte system can be used to develop cell therapeutics for a variety of diseases and can be used to load cells for both autologous and allogeneic therapies.

Cell Loading Alternatives to MaxCyte Lack Scalability, Efficiency & Clinical Utility

There are no direct substitutes or competing cell loading methods with MaxCyte's inherent safety or comparable production or treatment efficiencies. Programs requiring the insertion of molecules into cells for the development of commercializable therapies have limited options: Cell loading can be accomplished using viral vectors, chemical reagents, co-incubation or non-flow/passive electroporation, each with drawbacks. These methods are plagued by safety, scalability, logistical and regulatory issues that inhibit their use for therapeutic development.

Chemical reagents and co-incubation methods are generally known to lack the consistency and scalability necessary for commercialization. Adequate product is difficult to produce either in sufficient quantities or with enough consistency to satisfy regulatory requirements. Chemical methods also face practical and regulatory toxicity and purification requirements that add to the complexity, time and cost of clinical trials and commercial manufacture.

Although viral vector methods can effectively load cells, they are challenged by logistical and regulatory hurdles. Regulatory concerns about safety (carcinogenicity, unintended activity and toxicity) have resulted in the standard requirement for additional toxicology studies and their associated costs for viral methods. Scalability and consistency concerns also challenge such methods.

With its biologically neutral, FDA-cleared technology, MaxCyte avoids these challenges to cell loading and provides an approach that dramatically accelerates clinical development timelines by avoiding toxicity, reproductive toxicity and carcinogenicity studies due to its inherent simplicity and safety. As an example, one MaxCyte partner was able to submit an IND at least six months earlier than anticipated utilizing alternative methods.

Intellectual Property

MaxCyte's technology is protected by U.S. patents issued and allowed, and over 40 U.S. and international patents are pending.