Process Analytical Technology (PAT)

Within the framework of its Quality by Design initiative, the FDA defines Process Analytical Technologies as systems “for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.1” Process analytical technologies play a key role in enabling multivariate data acquisition and analysis, which is often the result of Design of Experiment (DOE) studies.

The LabChip GXII, an automated platform for rapid analysis of proteins and nucleic acids, has proven to be an enabling technology for DOE studies, particularly for Quality by Design programs for biological therapeutics, where it can be deployed as a Process Analytical Technology (PAT).  As an automated replacement technology for SDS-PAGE gels, the LabChip GXII provides high throughput analysis of titer, sizing, and purity analysis of proteins. The LabChip GXII can also be coupled with the Twister II Plate Handler for longer walk away time and can be integrated into a Staccato Workstation for complete automation of sample preparation and analysis.