CONCLUSIONS
We have developed and deployed the LC-MS and LC integrated µSI process analyzer systems for online MAM and glycan measurements in addition to designing the turn-key A2P2 system to accelerate development of attribute-centric biotherapeutic manufacturing processes. Key design considerations included instrument footprint reduction, faster result turnaround, software-driven features, capability consolidation, and operational simplification. These systems are designed to be simple to use and enable rapid execution of complex assays that can inform process development. Additionally, they can be readily integrated into a strategy thereby enabling real-time, attribute-focused process development, monitoring, and control. Rapid availability of critical quality attribute data provides insights that can guide purposeful planning of subsequent experiments. Efficiency gains through the integration of fluidic miniaturization, autonomous diagnostics, and advanced analytics are substantial and lead to efficient development of processes that consistently manufacture high quality products.