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Related Concept Videos

Upstream Processing01:27

Upstream Processing

84
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...
84
Batch vs Continuous Culture01:14

Batch vs Continuous Culture

148
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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Scale-Up Processes01:14

Scale-Up Processes

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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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Bioreactor Design and Operational System01:29

Bioreactor Design and Operational System

124
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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Production of Pharmaceuticals01:30

Production of Pharmaceuticals

66
Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under...
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Fed-Batch Culture01:23

Fed-Batch Culture

130
Fed-batch culture is a widely used bioprocessing strategy combining aspects of batch culture with controlled substrate feeding to optimize cell growth and product formation. In this semi-closed system, nutrients are strategically added during fermentation, while the accumulated products and biomass remain within the bioreactor until the end of the operation. This controlled addition of substrates allows for better management of growth kinetics, nutrient limitation, and metabolite...
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Related Experiment Video

Updated: Apr 9, 2026

Automated Counterflow Centrifugal System for Small-Scale Cell Processing
04:49

Automated Counterflow Centrifugal System for Small-Scale Cell Processing

Published on: December 12, 2019

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Developing the biofacility of the future based on continuous processing and single-use technology.

Stephan Klutz1, Jorgen Magnus2, Martin Lobedann1

  • 1Invite GmbH, Chempark Leverkusen, Building W32, 51373 Leverkusen, Germany.

Journal of Biotechnology
|June 21, 2015
PubMed
Summary
This summary is machine-generated.

This study demonstrates the first fully continuous manufacturing platform for monoclonal antibodies using 100% single-use equipment. This innovative approach offers a faster, more flexible, and sustainable alternative to traditional biopharmaceutical production.

Keywords:
Ballroom conceptClosed processingContinuous countercurrent diafiltrationContinuous processingMonoclonal antibodySingle-use

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Area of Science:

  • Biopharmaceutical manufacturing
  • Chemical Engineering
  • Process Development

Background:

  • Traditional large-scale batch manufacturing relies on stainless steel equipment, limiting flexibility.
  • The biopharmaceutical industry requires adaptable, small-scale, and flexible production processes.
  • The "biofacility of the future" concept emphasizes speed, flexibility, sustainability, and cost-effectiveness.

Purpose of the Study:

  • To establish the proof of concept for a continuously operated platform process for monoclonal antibody production.
  • To present the design principles and operational strategies for a fully continuous, single-use bioprocess.
  • To demonstrate the feasibility of automated, continuous upstream and downstream processing.

Main Methods:

  • Development and implementation of a pilot plant utilizing 100% single-use equipment.
  • Operation of a fully continuous upstream and downstream process for monoclonal antibody production.
  • Integration of continuous filtration, viral inactivation, chromatography, and formulation steps.

Main Results:

  • Successful operation of a pilot plant for continuous monoclonal antibody manufacturing.
  • Demonstration of continuous processing across all upstream and downstream unit operations.
  • Produced monoclonal antibodies met industrial bulk drug substance specifications.

Conclusions:

  • Continuous manufacturing using 100% single-use equipment is a viable and effective approach for monoclonal antibody production.
  • The developed platform offers a significant advancement over traditional batch processing.
  • This innovative approach supports the "biofacility of the future" concept, enabling faster, more flexible, and sustainable biopharmaceutical manufacturing.