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.