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Related Concept Videos

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...
Vaccine Production01:23

Vaccine Production

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...
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...
Fed-Batch Culture01:23

Fed-Batch Culture

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...
Drug Biotransformation: Overview01:16

Drug Biotransformation: Overview

Pharmaceutical substances known as xenobiotics are predominantly lipophilic and nonionized. This enables them to permeate lipid bilayers, such as cell membranes, and interact with intracellular target receptors. Lipophilic drugs have an advantage in crossing biological barriers and reaching their intended sites of action. However, lipophilic drugs often have a restricted capacity for renal expulsion or elimination from the body. When these drugs enter the kidneys and undergo glomerular...

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Automated Counterflow Centrifugal System for Small-Scale Cell Processing
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Published on: December 12, 2019

Continuous downstream processing of biopharmaceuticals.

Alois Jungbauer1

  • 1Department of Biotechnology, University of Natural Resources and Life Sciences Vienna--BOKU, Vienna, Austria. alois.jungbauer@boku.ac.at

Trends in Biotechnology
|July 16, 2013
PubMed
Summary

Continuous manufacturing offers significant advantages for biopharmaceutical production, including improved productivity and robust purification of sensitive biomolecules. This approach is becoming increasingly viable due to advancements in chromatography and regulatory acceptance.

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Area of Science:

  • Biotechnology
  • Chemical Engineering
  • Pharmaceutical Manufacturing

Background:

  • Batch processing remains the standard in biotechnology, despite its limitations.
  • Continuous manufacturing offers potential benefits like increased productivity and reduced footprint.
  • Biotechnology has been slow to adopt continuous manufacturing compared to other industries.

Purpose of the Study:

  • To highlight the advantages of continuous manufacturing in biopharmaceutical production.
  • To discuss the available unit operations for continuous downstream processing.
  • To address the challenges and drivers for implementing continuous manufacturing in biotechnology.

Main Methods:

  • Review of existing unit operations for downstream processing.
  • Analysis of advancements in continuous chromatography.
  • Examination of regulatory and economic factors influencing adoption.

Main Results:

  • Continuous operation can enhance process productivity and reduce physical footprint.
  • Continuous chromatography is a mature technology enabling continuous downstream processing.
  • Regulatory challenges regarding 'batch' definition have been addressed.

Conclusions:

  • Continuous manufacturing is a viable and beneficial strategy for biopharmaceutical production.
  • Economic pressures and flexibility needs will drive the adoption of continuous manufacturing.
  • Parametric release considerations further support the shift towards continuous processing.