A Simple Microfluidic Cell-Transfection Device for Making CGT Safer, Affordable and Successful

Abstract Cell/gene-therapy (CGT) poises to become common medical procedures in the coming years for curing not just rare diseases, but also many prevailing but difficult-to-treat ones. A practical enabling tool is urgently needed to address the challenges facing CGT, whose market size is estimated to be about ~$15B today and ~$82B by 2032. In a typical CGT procedure, a patient''s immune cells are engineered outside the body (ex vivo) before infusing back to specifically target and kill cancer cells. The current method for engineering cells with gene-editing molecules, a process known as cell transfection, utilizes mainly viral vectors such as retrovirus or lentivirus. Though regarded as harmless, these viral vectors have led to problems and concerns including random integration of viral DNA into the host genome, adverse immunogenic responses to viral particles, as well as limited cargo capacity, poor efficiency, poor cell viability and limited throughput. Moreover, the high cost and stringent safety measures associated with virus production and utilization have attributed to the sky-high price-tag for CGT treatment procedures. A non-viral transfection method can make CGT significantly safer and affordable, but it has its own problems including low yields, uneven gene delivery, reduced cell viability, etc. Since the number of cells taken from a patient for a treatment is limited, any of these problems could lead to a failure for the CGT treatment. To overcome these challenges and ensure a successful outcome for every CGT treatment, we are developing a simple, continuous flow-through, clog-free and high-throughput non-viral cell transfection device for delivering high transfection efficiency, consistency and cell health. Our team has the required domain expertise and experiences in related scientific subjects including microfluidics, bioengineering, nanomedicine and cancer treatment areas to overcome the technical hurdles and pave the way towards commercialization.