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Related Concept Videos

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...
Designing Growth Media for Bioreactors01:30

Designing Growth Media for Bioreactors

Growth media provide essential nutrients that support cell growth and metabolism, thereby enhancing the yield of valuable products such as enzymes, antibiotics, and biomass. Designing an effective growth medium involves balancing all components to prevent nutrient limitations or toxic excesses, both of which can impair growth and reduce product yields.Composition of a Typical Growth MediumA typical growth medium contains carbon and nitrogen sources, salts, vitamins, trace elements, and...
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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Use of High-Throughput Automated Microbioreactor System for Production of Model IgG1 in CHO Cells
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Developing a Model for Virus Contamination in Perfusion Bioreactors to Establish Rational Control Strategies for

Takao Ito1, Takashi Nihei2, Koichi Yamamoto3

  • 1Merck Ltd. (An Affiliate of Merck KGaA, Darmstadt, Germany), Koto-ku, Tokyo, Japan.

Biotechnology and Bioengineering
|May 14, 2025
PubMed
Summary

A new model assesses viral contamination in continuous biomanufacturing, showing daily sampling and 9 LRV clearance ensures product safety even with undetected viruses.

Keywords:
clearancecontinuous manufacturingmodelperfusion bioreactorsamplingviral safety strategyvirus contaminationvirus safety strategy

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Area of Science:

  • Biotechnology
  • Virology
  • Process Engineering

Background:

  • Continuous biomanufacturing requires robust viral safety strategies.
  • Assessing viral contamination impact on downstream clearance is critical.

Purpose of the Study:

  • Develop a viral contamination model for steady-state perfusion cell culture.
  • Evaluate the effect of sampling frequency and volume on viral clearance factor.
  • Assess virus risk in integrated continuous biomanufacturing.

Main Methods:

  • Population balance rate equations for cells and virions.
  • Incorporation of virus infection cycle and cell retention device sieving.
  • Simulation of endogenous and adventitious virus contamination scenarios.

Main Results:

  • Model predicts viable cell density decline post-contamination (e.g., MVM from Day 4).
  • A total downstream clearance of >15 LRV is needed for 99.999% product safety.
  • Daily sampling and 9 LRV clearance are sufficient if undetected virus removal is planned.

Conclusions:

  • The model simulates viral contamination scenarios effectively.
  • It aids in assessing virus safety strategies for continuous biomanufacturing.
  • Optimized sampling and clearance strategies enhance bioprocess safety.