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A Novel Approach for Non-Invasive Continuous In-Line Control of Perfusion Cell Cultivations by Raman Spectroscopy.

A Graf1, J Lemke2, M Schulze2

  • 1Product Development, Sartorius Stedim Biotech GmbH, Göttingen, Germany.

Frontiers in Bioengineering and Biotechnology
|May 13, 2022
PubMed
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This summary is machine-generated.

Raman spectroscopy enables advanced monitoring and control in continuous biopharmaceutical manufacturing. This study demonstrates its effectiveness for maintaining steady glucose levels in perfusion processes, ensuring consistent product quality.

Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Analytical Technology
  • Spectroscopy

Background:

  • Continuous manufacturing offers efficiency and quality improvements in biopharma.
  • Perfusion processes require advanced Process Analytical Technology (PAT) for steady-state control.
  • Raman spectroscopy is a promising PAT tool for bioprocess monitoring.

Purpose of the Study:

  • To implement and validate Raman spectroscopy for real-time monitoring and control of perfusion processes.
  • To develop bioreactor and scale-independent quantitative models for key metabolites.
  • To demonstrate the application of Raman spectroscopy for controlling glucose levels in perfusion cultures.

Main Methods:

  • An in-line Raman spectroscopy flow cell was integrated into the harvest stream of a perfusion process.
Keywords:
CHO perfusion processRaman spectroscopyautomated glucose controlcontinuous manufacturingprocess analytical technologies (PAT)quality by design (QbD)

Related Experiment Videos

  • Quantitative models for glucose and lactate were developed using data from multiple bioreactor scales.
  • The glucose model was validated and used to control an external glucose feed in a perfusion bioreactor.

    • Main Results:

    • A validated glucose model achieved a Root Mean Square Error of Prediction (RMSEP) of approximately 0.2 g/L.
    • Raman spectroscopy successfully controlled glucose concentrations at 4 g/L and 1.5 g/L for extended periods with ±0.4 g/L variability.
    • The measurement method proved to be bioreactor and scale-independent.

    Conclusions:

    • Raman spectroscopy is a powerful tool for advanced process monitoring and control in continuous biopharmaceutical manufacturing.
    • The developed scale-independent models facilitate robust control strategies for perfusion processes.
    • This technology holds significant potential for enhancing the efficiency and consistency of biopharmaceutical production.