New Tools for Flexible Manufacturing As the Biopharma industry looks to manufacture multiple products at varying scales, process design will need fresh considerations to achieve optimal overall process economy. In the evolution of downstream processing technology, significant performance improvements in chromatography resins, process equipment design, and the emergence of single-use technologies have marked important milestones for the industry. In today's monoclonal antibody production environment, new manufacturing tools are needed to reduce costs and increase the output from facilities. Compression of process time, predictable performance and reduction in the number of operations without risk to the robustness of production are some of the means to this end. This presentation will discuss current trends in the capacity needed to produce monoclonal antibodies given market shares and medical indications and how creating flexibility to accommodate different scales and varying demand as well as additional products in a manufacturing facility will not only drive a company's ability to meet market needs with minimized need for CAPEX but also drive utilization of fixed costs and thus the COGS situation. Points to consider in designing processes upstream and downstream that help companies arrive at an optimized overall economy of manufacturing will be reviewed. Presenter: Steven Moore, GE Healthcare-Life Sciences Steven Moore is a Business Development Manager for GE Healthcare-Life Sciences’ ReadyToProcess™ Portfolio of Products and Technologies for the Single Use Market. As a former Project Manager, Steve developed an innovative software tool called the ReadyCircuit Konfigurator™ which allows end users to design their own single use, aseptic tubing assemblies or complete unit operations on-line and generate instant price quotations. Steve has also held positions in Research & Development, Product Engineering and Sales. Prior to joining GE, Steve worked at Praxair Company, and holds a Bachelor’s Degree in Mechanical Engineering from Marquette University and a Master’s Degree in Business Administration from Indiana Wesleyan University.