10155131Continuous Contamination Monitoring through Single-Cell Sequencing for Pharmaceutical Quality Control: Fast-track to Pilot DeploymentClosedCollaborative R&DInnovate UKGenomeKey is developing a revolutionary environmental monitoring system for pharmaceutical manufacturing that combines proprietary microfluidic concentration technology with next-generation DNA sequencing to enable rapid detection and identification of microbial contaminants. Current pharmaceutical quality control relies on traditional culture-based testing methods that require 6-14 days to detect contamination. Our innovation will reduce this to just 5 hours while providing superior strain-level identification capabilities. The system processes large-volume pharmaceutical manufacturing samples through an automated workflow that concentrates and isolates microbial cells, extracts DNA, and performs rapid sequencing analysis. This enables unprecedented speed and sensitivity in detecting potential contamination events during pharmaceutical production. The technology represents a step-change in manufacturing quality control, enabling real-time monitoring that could prevent costly batch losses through early contamination detection. Beyond accelerating testing, our whole-genome sequencing approach provides detailed insight into contamination sources and patterns. This capability will help drive regulatory modernisation in pharmaceutical manufacturing while delivering significant operational and cost benefits to end users. The system will integrate with existing pharmaceutical quality control infrastructure, enabling straightforward adoption within current good manufacturing practice environments. This innovation has potential to transform pharmaceutical environmental monitoring, supporting more efficient production of vital medicines while maintaining the highest quality standards. The project will establish UK leadership in next-generation pharmaceutical quality control technology with strong export potential to the global pharmaceutical manufacturing sector.