Accelerate Process Development With Automated Aseptic Sampling

Ideally, in bioprocess development, each cycle is short and generates data that contributes to process optimization. While this workflow can be accelerated by increasing the number of data points, this requires process samples to be collected and analyzed throughout an experiment, regardless of the time or day.

Process Analytical Technology (PAT) aims to build quality into biopharmaceutical processes by identifying and controlling critical process parameters (CPP) and critical quality attributes (CQA) within a defined design space. Thus, access to abundant near-real-time data becomes crucial, especially when leveraging PAT.

Automated aseptic sampling and reliable material delivery to on-line preparation and analytical instruments enhance the throughput and time coverage of PAT. Proper implementation of automated sampling reduces experiment duration and enables staff to focus on value-generating tasks like output evaluation and optimization step implementation. This approach can increase data density and immediacy, thereby shortening development cycles and enabling informed decision-making through rapid data feedback loops.

Here, the MAST® Autosampling Solution is evaluated as part of an automated PAT system implemented by Takeda Pharmaceuticals. Takeda aimed to streamline its bioprocess development cycles by making rapid, data-driven decisions but was challenged with a lengthy data delivery pipeline. Discover how the automated sampling systems improved resource efficiency, accelerated turnaround times, and produced data comparable to manual results.