Process Analytical Technology (PAT) tools and laboratory equipment are on the rise of late within biologics process development (PD) departments. First, we use PD as a testing ground for new PAT technologies, which we require before fully trusting the technologies to be as comparable and robust as the commonly used offline assay methods. Second, we also use it as a testing ground for novel PAT methods designed to track cQAs known to be at high risk for excursion during the process. Last, we are using PAT within PD to accelerate our research cadence, achieve faster data turnaround, and ultimately control the process. For example, the Waters Patrol instrument was deployed in a pilot plant facility, after scientifically sound testing, for titer and purity (low molecular weight fragments, aggregate, and charge variant assays) analysis. Here we demonstrate PAT robustness testing, new method development, and how the methods accelerate process development.

Using process analytical technology to accelerate process development

2019 Spring National Meeting

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