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Related Concept Videos

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...
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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...
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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...

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Related Experiment Video

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Nutrient Regulation by Continuous Feeding for Large-scale Expansion of Mammalian Cells in Spheroids
11:01

Nutrient Regulation by Continuous Feeding for Large-scale Expansion of Mammalian Cells in Spheroids

Published on: September 25, 2016

Equipment design considerations for large scale cell culture.

David M Marks1

  • 1DME Alliance Incorporated, 5012 Medical Center Circle, Allentown, USA (e-mail, david.marks@dmealliance.com.

Cytotechnology
|November 13, 2008
PubMed
Summary

This review addresses challenges in large-scale (LS) mammalian cell culture manufacturing. It suggests equipment design improvements for better productivity and reliability in Good Manufacturing Practice (GMP) environments.

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Published on: December 5, 2011

Area of Science:

  • Biopharmaceutical Manufacturing
  • Bioprocess Engineering
  • Cell Culture Technology

Background:

  • Biologics manufacturing success hinges on equipment design, yet processing implications are often overlooked.
  • Scaling up mammalian cell culture presents unique challenges and risks.
  • Increasing demand for biopharmaceuticals drives larger-scale cell culture operations.

Purpose of the Study:

  • To summarize documented process difficulties in serum-free large-scale (LS) cell culture.
  • To analyze engineering constraints in LS cell culture processes.
  • To propose practical equipment design considerations for GMP manufacturing.

Main Methods:

  • A systems approach to bioreactor design.
  • Review of documented process difficulties in serum-free LS cell culture.
  • Analysis of engineering constraints for LS bioprocesses.

Main Results:

  • Identified process difficulties unique to serum-free large-scale cell culture.
  • Analyzed typical engineering constraints for these processes.
  • Suggested equipment design considerations for enhanced productivity, reliability, and operability.

Conclusions:

  • A systems approach is crucial for effective LS bioreactor design.
  • Optimized equipment design is essential for successful GMP biologics manufacturing.
  • Addressing gas distribution, agitation, vessel design, SIP/CIP, and control is key.