Streamlined & De-risked Biologics Manufacturing

Capsugel offers cell-culture process development and optimization services to maximize our clients’ product quality.  Using a unique combination of modeling strategies, we are able to derive insights leading to the development of control strategies that maximize product quality.

We focus on extracting more information and understanding from bioreactor experiments to enable development of processes that consistently produce high-quality biotherapeutic products:

  • Real-time cell and protein analysis using the Modular Automatic Sampling Technology (MAST™) platform for aseptic sampling
  • In-line, on-line, and off-line analytical integration with the MAST platform
  • Development of databases for the aggregation, visualization and management of process data
  • Automated data analysis for the identification of critical process parameters and accurate prediction of performance

A new state-of-the-art laboratory has also been commissioned that can be used to develop, optimize, and scale up biotherapeutic manufacturing processes. In addition to the novel MAST platform, this lab offers an expanded range of capabilities:

  • A suite of bioreactors connected to a MAST system that enables automated sampling and delivery to a variety of analytical equipment and cell-retention devices
  • A custom automated data aggregation and visualization system for the rapid analysis of cell-culture data
  • A steam-in-place reactor for scale-up of optimized processes

The sampling challenges associated with maintaining sterility and processing high-density cell solutions have been resolved by development of the MAST platform. Enabling at-line analysis, MAST facilitates collection of real-time samples that can be obtained from multiple reactors and sent to a wide variety of devices for optimized process control, including analyzers, cell removal systems, sample-retain devices, and sample processes. MAST units have been installed at multiple client facilities and have taken thousands of samples in cell-culture, microbial, and downstream applications without loss of sample integrity or bioreactor sterility. Capsugel continues to expand the instrumentation that can be integrated with MAST.