New microfluidic technologies that enable manufacturing of safer, more precise, more cost effective cell therapies
Abstract: The commercialization of cell therapies from the research lab into treatments requires new approaches of biomanufacturing that address challenges of cost, reliability, safety, and durability. The manufacturing of cell products is further complicated by the variability of raw materials and processes that are poorly controlled. There are a number of opportunities offered by microfluidics technologies to lend precision to the biomanufacturing unit operations, as well as in the integration of fluidic pathways to streamline a more continuous manufacturing. We use this talk to highlight the microfluidics technologies developed in my laboratory that can address challenges of cell therapy manufacturing, including cell separations, cell engineering, ex vivo culture, and fill/sterility. In addition, the precise processing of cells is not enough—microfluidic technologies must match the throughput to achieve a clinical scale. I will describe how hundreds of channels can be seamlessly combined to scaleup throughput by over 3 orders of magnitude to process cells at liters per minute. I will further discuss some challenges in translating technologies out of the lab and into the hands of manufacturers, by relating lessons learned during validation steps. Currently, the technologies to be described are used by a number of clinical translational research labs and are being validated by several pharmaceutical companies.
Bio: Todd Sulchek is a Professor of Mechanical Engineering and conducts fundamental and applied research in the field of metrology, microsystems, and cell biomechanics. Dr. Sulchek’s research program creates new technologies based upon fundamentals of fluids, cell mechanical responses, and microsystem design that can manipulate cells in fundamentally new ways. The primary applications include the engineering and selection of cells suitable for biomanufacturing of immune cells and stem cells for regenerative medicine and to generate new knowledge in cell mechanical responses. Dr. Sulchek has extensive experience in translating science into technologies and technologies into products. His research has generated intellectual property and licensing agreements with both start-up and established technology companies. He is a co-founder of CellFE, dedicated to bringing cell therapies to all who need them by changing how cell are manufactured and has contributed to raising over $10M in venture-backed funds, revenue, and grants. At CellFE he leads the business development with pharmaceutical partners that have tested CellFE’s cell engineering product. During his career, Dr. Sulchek has received several distinctions, including the NSF CAREER Award, the Undergraduate Research Mentor of the Year Award, the CETL/BP Junior Faculty Teaching Excellence Award, the Lockheed Inspirational Young Faculty award, 2012 Petit Institute Above and Beyond Award, Class of 1940 Course Survey Teaching Effectiveness Award, and is a KEEN Faculty Innovation Fellow. At Georgia Tech he contributes to experiential learning, particularly the teaching of entrepreneurship through Create-X, Creative Destruction Labs, and the Inventure Prize. Prior to Georgia Tech, he was a Postdoctoral Researcher and Staff Scientist at Lawrence Livermore National Laboratory. Dr. Sulchek studied at Stanford University under the mentorship of Calvin Quate, the inventor of the atomic force microscope, and as a student developed the first high-speed liquid imaging and manufacturing instruments.
Professor, Mechanical Engineering