Control Strategy for Pharmaceutical Continuous Manufacturing  – Overview and Case Study

Mojgan Moshgbar, Ph.D.

The Continuous Processing in biopharmaceutical industry offer compelling benefits in terms of flexibility in production volumes and potential elimination of scale up efforts. However, the successful exploitation of this promising manufacturing paradigm requires a deep understanding of the differences between batch and continuous processes, in particular the time dependent nature of the physical and chemical characteristics of the in-process materials and the final product attributes.

  • In this talk an overview of typically observed continuous process Dynamics and Steady State will be provided. The relationship between process dynamics and the choice of in-process tests and sampling strategy; as well as some of the considerations for material traceability and final product release tests will be discussed.
  • Example of an advanced Control Strategy for SOD continuous processes, based on real-time process monitoring and control, using integrated PAT, predictive softsensors and Advanced Process Control will presented.
  • The presentation will also highlight some of the current technology gaps, especially in the area of measurement and sensory devices will be highlighted.
  • The presentation will conclude with remarks describing potential future trends and the need for pre-competitive collaboration in technology development, and advanced sensors and control, and remaining barriers to technology adoption (rapid changeover, training and knowledge management, etc.)