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Bioreactor Design and Operational System01:29

Bioreactor Design and Operational System

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...
Bioreactor Controls-I01:28

Bioreactor Controls-I

Maintaining optimal conditions within fermenters is essential for maximizing microbial productivity and ensuring process efficiency. This lesson focuses on key parameters—temperature, foam, pH, carbon dioxide, oxygen, and pressure—and their precise measurement and control strategies in fermentation systems.Temperature ControlTemperature regulation is critical due to the exothermic nature of many fermentation processes. In small laboratory fermenters, temperature is commonly monitored using...
Bioreactor Controls-II01:18

Bioreactor Controls-II

In aerobic fermentations, oxygen is vital for microbial growth and metabolite production. Since air comprises only about 20% oxygen and the gas is poorly soluble in water—just 9 ppm at 20°C—supplying sufficient oxygen becomes a critical challenge, especially in high-demand processes like yeast growth or citric acid production. Even a fully saturated broth may offer only a few seconds of oxygen availability.To address this, sterile or scrubbed air is introduced into the fermentor via a sparger...
Batch vs Continuous Culture01:14

Batch vs Continuous Culture

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...
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...
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...

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Related Experiment Video

Updated: Jun 11, 2026

Continuous Flow Chemistry: Reaction of Diphenyldiazomethane with p-Nitrobenzoic Acid
07:06

Continuous Flow Chemistry: Reaction of Diphenyldiazomethane with p-Nitrobenzoic Acid

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Process development and characterization for integrated continuous bioprocesses-Highlights from N-mAb.

Kevin Brower1, Kelly Wiltberger2, Claudia Berdugo3

  • 1Sanofi, Purification Development-Mammalian Platform, Framingham, Massachusetts, USA.

Biotechnology Progress
|January 30, 2024
PubMed
Summary
This summary is machine-generated.

This case study details the N-monoclonal antibody (mAb) process, focusing on integrated continuous bioprocesses (ICB) and control strategies from development to commercial manufacturing. It highlights unique aspects of ICB for mAb production.

Keywords:
integrated continuous bioprocessingintegrated process characterizationintegrated process designperfusionrisk assessment

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Chemical Engineering
  • Process Control

Background:

  • The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) developed the N-mAb case study.
  • Industry adoption of advanced manufacturing technologies like integrated continuous bioprocesses (ICB) requires effective teaching and learning tools.
  • Previous case studies, such as A-mAb, have explored similar concepts.

Purpose of the Study:

  • To support education and training in biopharmaceutical manufacturing.
  • To accelerate the adoption of integrated continuous bioprocesses (ICB) for monoclonal antibody (mAb) production.
  • To present the evolution of an integrated control strategy for ICB, focusing on unique elements.

Main Methods:

  • The N-mAb case study summarizes process design and characterization chapters.
  • It focuses on elements unique to integrated continuous bioprocesses (ICB).
  • The study traces the development of an integrated control strategy through various manufacturing stages.

Main Results:

  • The N-mAb case study provides a framework for understanding ICB for mAbs.
  • It details the progression of control strategies from early clinical phases to commercial manufacturing.
  • Unique aspects of ICB relevant to process design and characterization are highlighted.

Conclusions:

  • The N-mAb case study serves as a valuable educational resource for biopharmaceutical manufacturing.
  • It emphasizes the importance of integrated control strategies in advanced manufacturing processes.
  • Focusing on unique elements of ICB aids in accelerating technology adoption.