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Related Concept Videos

Upstream Processing01:27

Upstream Processing

89
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...
89
Production of Pharmaceuticals01:30

Production of Pharmaceuticals

77
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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Batch vs Continuous Culture01:14

Batch vs Continuous Culture

179
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...
179
Scale-Up Processes01:14

Scale-Up Processes

90
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...
90
Vaccine Production01:23

Vaccine Production

99
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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Fed-Batch Culture01:23

Fed-Batch Culture

146
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...
146

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A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
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Continuous processing for production of biopharmaceuticals.

Anurag S Rathore1, Harshit Agarwal, Abhishek Kumar Sharma

  • 1a Department of Chemical Engineering , Indian Institute of Technology , New Delhi , India.

Preparative Biochemistry & Biotechnology
|February 13, 2015
PubMed
Summary

Continuous bioprocessing offers significant advantages over traditional batch methods, including increased productivity and reduced processing times. This review examines recent advancements in continuous manufacturing for biotherapeutics.

Keywords:
bioprocessingbiotherapeuticscontinuous chromatographycontinuous processingcontinuous refolding

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Area of Science:

  • Biotechnology and biopharmaceutical manufacturing
  • Chemical and process engineering

Background:

  • Continuous processing is well-established in general manufacturing, offering benefits like reduced cycle times and higher productivity.
  • The biopharmaceutical industry is increasingly adopting continuous processing for biotherapeutics production.
  • While continuous upstream processing (perfusion) is established, recent advances in downstream processing are enabling integrated continuous platforms.

Purpose of the Study:

  • To review major developments in continuous bioprocessing over the past decade.
  • To discuss the advantages and disadvantages of various continuous processing approaches.
  • To highlight the industry's shift towards integrated continuous biomanufacturing.

Main Methods:

  • Literature review of recent advancements in continuous bioprocessing technologies.
  • Analysis of the pros and cons of different continuous processing strategies.
  • Examination of regulatory perspectives on continuous manufacturing.

Main Results:

  • Significant progress has been made in developing continuous downstream processing technologies.
  • Integrated continuous bioprocessing platforms are emerging as a viable alternative to batch processing.
  • Regulatory bodies are supportive of the transition to continuous manufacturing.

Conclusions:

  • Continuous bioprocessing presents a promising paradigm for more efficient and productive biotherapeutic manufacturing.
  • The integration of continuous upstream and downstream operations is key to realizing the full potential of this approach.
  • Further development and adoption of continuous technologies are expected, driven by industry and regulatory interest.