Recognizing that successful manufacturing lies on the critical path to successful delivery of therapeutics to the patient, we continually look for ways to improve process robustness and performance. Innovative process tool and technologies provide the opportunity to improve current processes through process intensification and design of new processes enabling advanced therapeutic products like genomic medicines. Using a framework of Quality, Speed, Cost and Flexibility we can design an innovation strategy for application of advanced tools and methods to meet demands of greater patient access and lower cost for both current and future manufacturing processes.