• 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… 

Current state of the art in continuous bioprocessing

TLDR
This review focusses on the current state of the art of continuous downstream processing, highlighting the key advantages over traditional batch manufacturing, and allows the identification of scenarios where continuous downstreamprocessing may be critical for commercial manufacturing success.

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White paper on high‐throughput process development for integrated continuous biomanufacturing

TLDR
The major gaps in HTPD are illustrated and the major needs and possible solutions to achieve an end-to-end Integrated Continuous Biomanufacturing are discussed, as discussed in the context of the 2019 ICB Conference.

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TLDR
This paper provides a review of the work that has been published in the literature on computational process design and economic analysis methods on continuous biopharmaceutical antibody production and its comparison with a conventional batch process.

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TLDR
A novel mathematical algorithm is introduced to determine the most optimal equipment scheduling configuration that maximizes the mass output for a facility producing a single product.

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TLDR
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Single pass diafiltration integrated into a fully continuous mAb purification process

TLDR
This work illustrates the feasibility of incorporating a single pass diafiltration step into an end‐to‐end continuous protein purification process and several critical design aspects were incorporated to minimize system complexity and reduce the buffer volume requirements.

Continuous Manufacturing of Recombinant Therapeutic Proteins: Upstream and Downstream Technologies.

TLDR
This review first discusses approaches for continuous cell culture, with a focus on perfusion-enabling cell separation technologies including gravitational, centrifugal, and acoustic settling, as well as filtration-based techniques.

Continuous counter‐current chromatography for capture and polishing steps in biopharmaceutical production

TLDR
Different continuous multi‐column chromatography processes are discussed, associated with increased productivity per cycle and decreased buffer consumption, whereas the typical purity‐yield trade‐off of classical batch chromatography can be surmounted by continuous processes for polishing applications.
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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
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TLDR
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TLDR
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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
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