• Corpus ID: 53003706

White Paper on Continuous Bioprocessing

@inproceedings{Cooney2014WhitePO,
  title={White Paper on Continuous Bioprocessing},
  author={Charles L Cooney and Konstantin B. Konstantinov},
  year={2014}
}
There is a growing interest in realizing the benefits of continuous processing in biologics manufacturing, which is reflected by the significant number of industrial and academic researchers who are actively involved in the development of continuous bioprocessing systems. These efforts are further encouraged by guidance expressed in recent FDA conference presentations. The advantages of continuous manufacturing include steady state operation, consistent product quality, reduced equipment size… 
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References

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TLDR
This review discusses the advantages of continuous processing for thermochemical rearrangements, immobilized catalysts, and microwave, photochemical, electrochemical, and sonochemical processes, and how these can be performed using equipment readily available for the laboratory and pilot plant.
Integrated continuous production of recombinant therapeutic proteins
TLDR
The first successful demonstration of the integration of a perfusion bioreactor and a four‐column periodic counter‐current chromatography system for the continuous capture of candidate protein therapeutics is reported, demonstrating the potential of integrated continuous bioprocessing as a universal platform for the manufacture of various kinds of therapeutic proteins.
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TLDR
The potential of CAC for industrial application is demonstrated by continuous isolation of rFVIII from cell culture supernatant in pilot scale, where thirty-fold concentration can be achieved at 94% yield, while purity is increased 3-5-fold.
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TLDR
To gauge the effect of extended culture lifetime on product quality, biochemical characteristics of MAb isolated from different time points in the fed‐batch culture were determined and it was revealed that MAb produced later in the culture contained greater percentages of truncated N‐acetylglucosamine and highmannose N‐glycans.
Continuous Countercurrent Tangential Chromatography for Monoclonal Antibody Purification
TLDR
A continuous countercurrent tangential chromatography system in which the resin flows sequentially through a series of static mixers and hollow fiber membrane modules to accomplish the binding, washing, elution, stripping, and equilibration steps in continuous operation with true countercurrent staging is tested.
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TLDR
Unusually high levels of the mannose‐5 (Man5) glycoform were observed during the early development of a therapeutic antibody produced from a Chinese hamster ovary cell line, model cell line A, and it has been hypothesized that specific enzyme activity in the glycosylation pathway could have been altered in this fed‐batch process.
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TLDR
A high cell density perfusion process of monoclonal antibody (MAb) producing Chinese hamster ovary (CHO) cells was developed in disposable WAVE Bioreactor™ using external hollow fiber filter as cell separation device and cell resuscitation was very successful, showing that this system was a reliable process for cell bank manufacturing.
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