Real-Time Insights and Real Results with LC-MS Automation

Ben Wilkes, Principal Biologics Market Development Manager at Waters discussed how using automated LC-MS analysis in biopharma development can enhance process development and improve efficiency. Wilkes’s discussion centred on process attribute monitoring, product monitoring, and connected bioprocessing. Avoiding product batch failure is critical to preventing massive financial losses. Wilkes explained: “By making the manufacturing and the process development and the product development more efficient and quicker, particularly analytics and release testing by using data-driven decisions, we can bring that lag of analytics and delays down from weeks to days.” Traditionally, upstream development campaigns run cell culture experiments which usually last two weeks per culture experiment. Then samples can be taken and sent to an analytical facility for various analyses with the turnaround time lasting between 4 and 6 weeks. Wilkes outlined the problematic implications of this lengthy timescale: “You'll be running the next set of culture experiments with limited visibility on the results from the previous experiment. Running blind leads to a poorly effective development process and it's not a robust manufacturing process and development process.” As a solution, Wilkes suggested using at-line analytics to provide near real-time analysis. Waters’ LC-MS system is an at-line analyser that allows samples and analysis to be taken in a matter of minutes. The BioAccord system analyses over 200 compounds in under 10 minutes with minimal sample preparation. By identifying known and unknown compounds with high accuracy, it optimizes feed strategies, enhances nutrient profiling, and supports vendor quality control. The BioAccord system also streamlines product analysis with workflows that provide comprehensive data on titre, purity, glycan profiling, and post-translational modifications (PTMs) within six minutes. It eliminates purification steps and uses minimal sample volumes, making it user-friendly for non-analytical scientists. Automated data processing generates actionable insights that researchers can use to improve product quality and yield. Collaborations with organisations like Jansen, Sartorius, and the University of Hannover demonstrate the practical benefits of LC-MS technology. Jansen used media analysis to identify factors causing cell viability drops. While Sartorius applied glycan profiling to optimise adaptive glucose feeding. Furthermore, Wilkes explored how Waters’ automation tools can be integrated to simplify sample preparation and process optimisation. He stated: “Using that data interface, we can adapt to system behaviour dynamically using the process variables in the Ambr software and also feed that into DoE studies to optimise cell culturing conditions and product quality.” Moreover, the JMP software integration automates data cleanup and visualisation, saving up to 80% of data analytics time. These connected systems enable a flow of information from process attributes to decision-making, improving efficiency across development pipelines. Wilkes demonstrated that by combining process monitoring, product analysis, and connected workflows, the BioAccord system accelerates biopharma development while reducing costs and enhancing data-driven decisions.