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Upstream Processing01:27

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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...
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Vaccine production involves a sequence of upstream and downstream processes to generate a safe and effective immunological product. It begins with cultivating microorganisms, such as viruses or bacteria, to obtain antigenic material. For viral vaccines, mammalian host cells are grown in bioreactors and subsequently infected with the target virus. The virus replicates within the host cells, which are lysed to release viral particles. This lysate is then clarified through filtration or...
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Fermentation is a foundational biotechnological process used to produce pharmaceuticals, biofuels, enzymes, and food additives. Among industrial strategies, batch and continuous fermentation are the two most widely applied. Although both rely on microbial conversion of substrates into desired products, they differ markedly in operation, productivity, and suitability for specific applications.Batch fermentation occurs in a closed system in which nutrient media and inoculum are added at the...
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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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Continuous downstream processing for high value biological products: A Review.

Andrew L Zydney1

  • 1Department of Chemical Engineering, The Pennsylvania State University, University Park, Pennsylvania, 16802. zydney@engr.psu.edu.

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|July 9, 2015
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Summary

Continuous bioprocessing offers reduced costs and facility size for high-value biological products. This review explores separations technology for continuous downstream manufacturing, including chromatography, for monoclonal antibody production.

Keywords:
bioprocessingbioseparationschromatographycontinuous processesdownstream processingsimulated moving bed

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Area of Science:

  • Biotechnology and Bioprocessing
  • Chemical and Biochemical Engineering

Background:

  • Growing demand for large-scale, cost-effective production of high-value biological products.
  • Continuous processing offers potential for reduced costs, smaller facilities, and improved product quality.
  • Need for flexible, multi-product manufacturing facilities.

Purpose of the Study:

  • To review the state-of-the-art in separations technology for continuous downstream bioprocessing.
  • To identify unit operations suitable for continuous production of secreted proteins, such as monoclonal antibodies.
  • To highlight advancements and challenges in continuous chromatographic separations.

Main Methods:

  • Review of current separations technologies applicable to continuous bioprocessing.
  • Focus on unit operations including cell separation, initial product recovery (capture), purification (polishing), and formulation.
  • Analysis of available options for continuous chromatographic separations.

Main Results:

  • Identified key separations technologies suitable for continuous downstream processing.
  • Highlighted the importance and availability of continuous chromatographic methods.
  • Acknowledged ongoing challenges in developing fully integrated continuous bioprocesses.

Conclusions:

  • Continuous bioprocessing presents a viable strategy for efficient manufacturing of biological products.
  • Technological advancements are providing attractive options for developing integrated continuous processes.
  • Further development is needed to overcome challenges in implementing fully continuous biomanufacturing.