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Downstream Processing01:29

Downstream Processing

Downstream processing begins once fermentation is complete and involves a series of steps to recover and purify products such as acids, vitamins, antibiotics, or proteins.Cell HarvestingFor example, for intracellular protein-based products, the first step is harvesting the cells. This is typically achieved using centrifugation or filtration to separate the cells from the liquid phase.Cell Disruption for Intracellular ProductsIf the target product is intracellular, the harvested cells must be...
Upstream Processing01:27

Upstream Processing

Upstream processing represents a critical phase in biomanufacturing, wherein biological systems such as microorganisms, mammalian cells, or insect cells are cultivated to produce therapeutic proteins, vaccines, enzymes, or other biologically derived products. This phase encompasses all steps from the selection and genetic manipulation of the production organism to the cultivation of cells in bioreactors under tightly controlled environmental conditions.Host Selection and Genetic OptimizationThe...
Scale-Up Processes01:14

Scale-Up Processes

The scale-up of microbial fermentation processes is essential in industrial biotechnology, allowing the transition from laboratory-scale experiments to commercial-scale production while aiming to maintain product yield and quality. This process requires meticulous adjustment of equipment design, process parameters, and contamination control strategies to accommodate increasing culture volumes.At the laboratory scale, cultures are typically maintained in 1 to 10-liter glass or autoclavable...

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Related Experiment Video

Updated: Jun 7, 2026

An Economical and Versatile High-Throughput Protein Purification System Using a Multi-Column Plate Adapter
10:08

An Economical and Versatile High-Throughput Protein Purification System Using a Multi-Column Plate Adapter

Published on: May 21, 2021

Scale-up of protein purification: downstream processing issues.

John Joseph Milne1

  • 1BioUetikon Ltd, Dublin City University, Dublin, Ireland. john.milne@biouetikon.com

Methods in Molecular Biology (Clifton, N.J.)
|October 28, 2010
PubMed
Summary
This summary is machine-generated.

Scaling up chromatography for therapeutic protein purification is crucial. This review highlights key factors for maintaining product purity and integrity during large-scale operations.

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Last Updated: Jun 7, 2026

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Area of Science:

  • Biochemistry
  • Chemical Engineering
  • Pharmaceutical Manufacturing

Background:

  • Chromatography is essential for downstream processing of therapeutic proteins.
  • Rising product titers necessitate economic improvements in purification.
  • Commercial manufacturing requires scaling up chromatography from lab-based optimizations.

Purpose of the Study:

  • To review critical factors for scaling chromatography operations.
  • To ensure product purity and integrity are maintained during scale-up.

Main Methods:

  • Literature review of chromatography scale-up challenges.
  • Analysis of key process parameters affecting large-scale purification.

Main Results:

  • Scale-up requires careful consideration of chromatography parameters.
  • Maintaining product quality at larger scales is achievable with strategic planning.

Conclusions:

  • Successful chromatography scale-up is vital for efficient therapeutic protein manufacturing.
  • Addressing scale-dependent factors ensures consistent product quality.