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Bridging the gap between PAT concepts and implementation: An integrated software platform for fermentation.

Viki R Chopda1, James Gomes2, Anurag S Rathore3

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|December 10, 2015
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Summary

Developing integrated visual programming software for bioreactor control enhances real-time monitoring and product quality. This approach offers improved process management and easier implementation of Process Analytical Technology (PAT) initiatives.

Keywords:
Bioprocess controlData acquisitionInterfacingMonitoringVisual programming

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Area of Science:

  • Biotechnology
  • Process Engineering
  • Software Development

Background:

  • Bioreactor control is critical for product yield and quality, with complexity increasing in large-scale manufacturing.
  • The Process Analytical Technology (PAT) initiative demands robust monitoring and control for real-time adjustments based on critical quality attributes (CQA) and critical process parameters (CPP).
  • Current commercial software limitations hinder the flexibility required for advanced bioreactor control strategies.

Purpose of the Study:

  • To develop an integrated visual programming environment for a Sartorius BIOSTAT® B Plus 5L bioreactor.
  • To interface various peripheral devices with the bioreactor system.
  • To facilitate real-time data access and control actions for precise trajectory following.

Main Methods:

  • Utilized a visual programming environment for software development.
  • Integrated the software with a Sartorius BIOSTAT® B Plus 5L bioreactor.
  • Interfaced multiple peripheral devices to the bioreactor system for comprehensive data acquisition and control.

Main Results:

  • Achieved real-time data access and execution of control actions.
  • Demonstrated improved real-time monitoring and control capabilities.
  • Showcased reduced variability, improved performance, and enhanced knowledge management.

Conclusions:

  • The integrated visual programming system offers significant benefits for bioreactor operations.
  • This approach simplifies Process Analytical Technology (PAT) implementation and reduces operator training time.
  • The developed software enhances overall bioreactor performance and product consistency.