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Related Concept Videos

Bioreactor Design and Operational System01:29

Bioreactor Design and Operational System

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Bioreactors are engineered vessels designed to cultivate microorganisms under controlled conditions for industrial bioprocessing. They maintain sterility and allow precise regulation of pH, temperature, oxygen, and nutrient levels to optimize microbial growth and metabolite production. Bioreactors range from small laboratory units of 1 liter to industrial systems holding up to 500,000 liters, though only about 75% of their volume is actively used for fermentation. The remaining headspace...
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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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Automated vertical wheel bioreactor integrated with process analytics for T-cell manufacturing.

Bryan Wang1, Bharat Kanwar2, Annie C Bowles-Welch3

  • 1Marcus Center for Therapeutic Cell Characterization and Manufacturing, Parker H. Petit Institute of Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, Georgia, USA; Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Atlanta, Georgia, USA; School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, Georgia, USA; NSF Engineering Research Center (ERC) for cell Manufacturing Technologies (CMaT), Atlanta, Georgia, USA.

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Summary
This summary is machine-generated.

This study presents a novel bioreactor platform for automated cell therapy manufacturing. It integrates process analytical technologies (PAT) for real-time monitoring and control, improving T cell biomanufacturing quality and reproducibility.

Keywords:
T cellsautomationbioreactor designcell therapy manufacturingprocess analytical technologyprocess development

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Area of Science:

  • Biotechnology
  • Cell Therapy Manufacturing
  • Process Engineering

Background:

  • Cell therapy biomanufacturing is complex, with variability impacting product quality.
  • Automated systems and process analytical technologies (PAT) are crucial for reproducible manufacturing.

Purpose of the Study:

  • To develop and demonstrate a closed-system bioreactor platform for T cell biomanufacturing.
  • To integrate automated controls and PAT for enhanced process monitoring and control.

Main Methods:

  • Identified critical process parameters (CPPs) using spent media analysis and symbolic regression.
  • Optimized process development for primary human T cells and chimeric antigen receptor (CAR) T cells.
  • Integrated closed-loop automation and real-time imaging for continuous monitoring.

Main Results:

  • Successfully demonstrated closed-system T cell biomanufacturing using the developed platform.
  • Identified and validated CPPs for T cell expansion.
  • Integrated multiplexed PAT for real-time analytics and feedback control.

Conclusions:

  • The bioreactor platform offers a proof-of-concept for integrated PAT and intelligent automation.
  • Enables discovery, monitoring, and control of critical quality attributes and CPPs.
  • Facilitates reproducible and efficient cell therapy manufacturing.