
Company BackgroundMaxCyte is a clinical-stage cell therapeutics company with a rapidly growing pipeline of product development partnerships in cell-based therapies. The Company's proprietary, non-viral, ex vivo cell loading technology provides safety, scalability and reproducibility capabilities which are fundamental to commercializing successful cell-based therapies. MaxCyte has demonstrated the value of its versatile technology in partnered therapeutic programs in oncology, pulmonary, metabolic and infectious diseases as well as in development collaborations with leading researchers. Current clinical programs with MaxCyte-engineered cells include: a Phase IIa clinical study for treatment of chronic lymphocytic leukemia (CLL) and a Phase IIa study using engineered stem cells for the treatment of primary Pulmonary Arterial Hypertension (PAH). MaxCyte has recently partnered with Medinet (JP) to commercialize a cell based therapy to be launched in 2008. In addition, there are advanced preclinical programs in oncology and regenerative medicine. More than 16 commercial and academic partners are currently using the MaxCyte technology. The MaxCyte system has an FDA Master File in place at the Center for Biologics Evaluation and Research (CBER).MaxCyte's HistoryMaxCyte was founded in 1999 to commercialize flow electroporation technology exclusively from the CBR Institute for Biomedical Research. The technology was intended for clinical use, and the application that had been proposed when the technology was first acquired involved loading 1 liter of autologous red blood cell suspension with an alternative hemoglobin oxygen modulator to yield a therapy for ischemic disorders. MaxCyte set out to pursue the red blood cell application and to investigate use of the technology for loading a wide range of biologically active molecules into many types of cells. The system has been significantly refined and many applications explored, but the original plan, to develop a system primarily intended for clinical use in a near patient setting, has been the guiding principle.MaxCyte Facilities and ResourcesMaxCyte occupies a 14,000 sq ft facility in Gaithersburg, Maryland. More than 50% of the facility is dedicated to research and development. The molecular/cell biology laboratory is ~ 5,000 sq. ft equipped with general laboratory equipment, including Q-PCR and PCR instruments, spectrophotometer, pH meter, fluorescent microscopes, water baths, bench top centrifuges, -20°C and -80°C freezers and MaxCyte proprietary systems. There are separate tissue culture rooms with large tissue culture hoods, CO2 incubators and all other general equipment for tissue culture. In addition we have a WAVE bioreactor system with a capacity to culture of suspension cells. Other general lab equipment includes Becton Dickinson FACS Calibur flow cytometers, a liquid nitrogen storage system, high speed centrifuges, bacterial culture incubators, glass washer and autoclave, dark room, and a multi-well plate readers. MaxCyte engineers occupy a space where they design, develop, assemble and manufacture the electroporation instrumentation and cell processing chambers. |