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Process analytical technology implementation for protein refolding: GCSF as a case study.

Vishwanath Hebbi1, Garima Thakur1, Anurag S Rathore1

  • 1Department of Chemical Engineering, Indian Institute of Technology, Hauz Khas, India.

Biotechnology and Bioengineering
|December 16, 2018
PubMed
Summary
This summary is machine-generated.

Process analytical technology (PAT) enhances biopharmaceutical manufacturing by enabling real-time monitoring of protein refolding. This statistical process control approach ensures consistent product quality through effective process management.

Keywords:
multivariate data analysisprocess analytical technologyprocess controlprotein refoldingstatistical process control

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Analytical Technology (PAT)
  • Protein Refolding

Background:

  • Protein refolding is critical for therapeutic protein production but is sensitive to process parameters and buffer attributes.
  • Ensuring consistent product quality necessitates robust process control and monitoring during refolding.
  • Current methods may lack real-time insights into critical stages of protein refolding.

Purpose of the Study:

  • To develop and demonstrate a statistical process control (SPC) approach for monitoring protein refolding.
  • To integrate online measurements for real-time process oversight from buffer preparation to refold quenching.
  • To enable consistent therapeutic protein manufacturing using Escherichia coli-based systems.

Main Methods:

  • Utilized online measurements of redox potential, temperature, and pH.
  • Developed a statistical model based on these critical process parameters.
  • Integrated the statistical model with LabView for real-time monitoring and control.

Main Results:

  • The developed system successfully monitored the protein refolding process in real-time.
  • The statistical model effectively identified process deviations during manufacturing.
  • Demonstrated the capability to enable process control for consistent product quality.

Conclusions:

  • The proposed PAT approach provides a robust method for statistical process control of protein refolding.
  • Real-time monitoring and control are crucial for achieving consistent quality in therapeutic protein manufacturing.
  • This system facilitates improved process understanding and management in biopharmaceutical production.