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Scale-Up of Protein Purification: Downstream Processing Issues.

John Joseph Milne1

  • 1National Institute for Bioprocessing Research and Training (NIBRT), Foster's Avenue, Blackrock, Co., Dublin, Ireland. john.milne@nibrt.ie.

Methods in Molecular Biology (Clifton, N.J.)
|October 13, 2016
PubMed
Summary
This summary is machine-generated.

This review addresses challenges in scaling up chromatography processes for therapeutic proteins. It highlights key factors for maintaining product purity and integrity during large-scale biopharmaceutical manufacturing.

Keywords:
ChromatographyDownstream processingProtein purificationScale-up

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Separation Science
  • Protein Purification

Background:

  • Separation science is crucial for downstream processing of therapeutic proteins.
  • Increasing product titers and new biopharmaceuticals challenge current purification methods.
  • Scaling up chromatography from lab to commercial manufacturing requires careful consideration.

Purpose of the Study:

  • To review critical factors for scaling chromatography processes.
  • To ensure product purity and integrity are maintained during scale-up.
  • To improve the robustness and economics of biopharmaceutical purification.

Main Methods:

  • Literature review of chromatography scale-up challenges.
  • Analysis of key process parameters affecting purification at scale.
  • Discussion of strategies for maintaining product quality.

Main Results:

  • Scale-up requires careful management of chromatography parameters.
  • Maintaining product purity is feasible with appropriate process adjustments.
  • Optimized scale-up can enhance the economics of manufacturing.

Conclusions:

  • Successful scale-up of chromatography is essential for biopharmaceutical production.
  • Addressing scale-dependent factors ensures consistent product quality.
  • Further optimization of chromatography processes is needed for efficiency.