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Scale-Up of Protein Purification: Downstream Processing Issues.

John Joseph Milne1

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

Methods in Molecular Biology (Clifton, N.J.)
|August 30, 2023
PubMed
Summary
This summary is machine-generated.

Scaling up chromatography is essential for biopharmaceutical manufacturing, especially for new therapies like gene therapy. Careful consideration of scale-up factors ensures product purity, yield, and quality are maintained from development to commercial production.

Keywords:
ChromatographyDownstream processingProtein purificationScale-up

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Downstream Processing
  • Chromatographic Separations

Background:

  • Chromatography is central to purifying therapeutic proteins.
  • Emerging therapies like gene therapy will also rely on chromatography.
  • Cell culture intensification presents challenges to chromatography robustness and economics.

Purpose of the Study:

  • To discuss key factors in chromatography scale-up.
  • To ensure purity, yield, and quality are maintained during scale-up.
  • To address challenges posed by process intensification.

Main Methods:

  • Discussion of critical factors in chromatography operations.
  • Modeling considerations during process scale-up.
  • Analysis of scale-up impact on product quality.

Main Results:

  • Scale-up of chromatography unit operations is necessary for commercial manufacturing.
  • Maintaining product purity, yield, and quality requires careful scale-up planning.
  • Process intensification strategies necessitate robust chromatography scale-up.

Conclusions:

  • Chromatography scale-up is a critical step for biopharmaceutical production.
  • Effective scale-up strategies are vital for new therapeutic modalities.
  • Addressing scale-up challenges ensures reproducible commercial manufacturing.