Accelerated process development requires rapid decision-making capabilities. Current offline sample testing approaches have long data turn-around times (TAT), are expensive and require extensive resources. PAT technology enables real time/right time testing resulting in improved process control and process knowledge while minimizing FTE resources. A cross-functional team comprising upstream, downstream engineers and analytical scientists successfully developed a non-GMP bench scale bioreactor model with online purification and product quality testing. Attributes monitored include process performance, titer, aggregation, charge variants, and post-translational modifications (PTMs). Results from traditional bench scale model (offline methods) were compared to online methods. Comparative results, a 10x reduction in data TAT, and >65% reduction in FTE resources per testing panel was observed compared to conventional testing. This co-laboratory model will be employed for future bench scale and pilot scale development enabling acceleration of product development activities.
Attendees will learn how to accelerate process development using the MAST® Automated Sampling System:
- Automated process developed using a cross functional team with upstream and downstream engineers and analytical scientists
- Measured product quality attributes including titer, aggregation, charge variants and post-translational modifications
- Resulted in 10-fold reduction in total analytical time
- Reduced FTE required by 65%
