The use of windows of operation as a bioprocess design tool

Woodley, John M.; Titchener-Hooker, NJ

doi:10.1007/s004490050215

Cited by 33 publications

(52 citation statements)

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“…Part of the rationale for this research was the need to make process design decisions quickly, especially in the pharmaceutical industry where pressure to get to market is great. More recently the representation of the process data has been examined in the form of "process maps" -a graphical technique to visualise the conditions acceptable to the biocatalyst in the reactor [62,63]. This enables sensitivity analyses and process flexibility along with alterations to the process to be examined using a graphical tool.…”

Section: Process Designmentioning

confidence: 99%

Advances in Enzyme Technology — UK Contributions

Woodley

2000

History of Modern Biotechnology II

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Enzyme technology has been a recognised part of bioprocess engineering since its inception in the 1950s and 1960s. In this article the early history of enzyme technology is discussed and the subsequent developments in enzyme isolation, enzyme modification and process technology are described. These creative developments have put enzyme technology in a position of huge potential to contribute to environmentally compatible and cost effective means of industrial chemical synthesis. Recent developments in protein modification to produce designer enzymes are leading a new wave of enzyme application.

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Section: Process Designmentioning

confidence: 99%

Advances in Enzyme Technology — UK Contributions

Woodley

2000

History of Modern Biotechnology II

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“…Figures 5 and 6 provide information which aids in the construction of windows of operation, 16 thereby enabling identification of the optimal operating conditions for a process. For example, based on Fig.…”

Section: Gsa As a Technique For Developing Windows Of Operationmentioning

confidence: 99%

Global sensitivity analysis for the determination of parameter importance in the chromatographic purification of polyclonal antibodies

Chhatre

Francis²,

Newcombe³

et al. 2007

J of Chemical Tech & Biotech

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BACKGROUND: The financial and technical challenges currently being faced by the pharmaceutical industry have prompted the development of computer models that rapidly evaluate manufacturing strategies for commercialscale drug production. The utility of a model is enhanced by the application of sensitivity analysis techniques (SA), which seek to quantify the relative importance of different input variables. Among several SA methods available, global sensitivity analysis (GSA) provides a powerful means of ranking inputs based on the contribution that each makes towards the variance of a model. To demonstrate the value of the approach, this paper describes the application of GSA to a mathematical model of the synthetic adsorbent-based chromatographic capture of antibodies from ovine serum, a strategy being considered by Protherics UK Limited for production of an FDA-approved rattlesnake anti-venom.

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“…Windows of Operation provide one such tool, which will help in design and also enable the rapid comparison of alternative operating strategies. Previous work has demonstrated the use of Windows of Operation as a visualisation tool within bioprocessing (King et al, 2004;Nealon et al, 2005;Woodley and Titchener-Hooker, 1996;Zhou and Titchener-Hooker, 1999;Zhou et al, 1997). Such Windows have not only been shown to be useful in the selection of suitable operating conditions for a given processing objective but also to indicate where a particular item of equipment is not suitable for the chosen process target.…”

Section: Introductionmentioning

confidence: 98%

A methodology for centrifuge selection for the separation of high solids density cell broths by visualisation of performance using windows of operation

Salte

King

Baganz

et al. 2006

Biotechnol. Bioeng.

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Expression systems capable of growing to high cell densities are now readily available and are popular due to the benefits of increased product concentration. However, such high solids density cultures pose a major challenge for bioprocess engineers as choosing the right separation equipment and operating it at optimal conditions is crucial for efficient recovery. This study proposes a methodology for the rapid determination of suitable operating conditions for the centrifugal recovery of high cell density fermentation broths. An ultra scale-down (USD) approach for the prediction of clarification and dewatering levels achieved in a range of typical high-speed centrifuges is presented. Together with a visualisation tool, a Window of Operation, this provides for the rapid analysis of separation performance and evaluation of the available operating conditions, as an aid in the selection of the centrifuge equipment most appropriate for a given process duty. A case study examining centrifuge selection for the processing of a high cell density Pichia pastoris culture demonstrates the method. The study examines semi-continuous disc-stack centrifuges and batch-operated machines such as multi-chamber bowls and Carr Powerfuges. Performance is assessed based on the variables of clarification, dewatering and product yield. Inclusion of limits imposed by the centrifuge type and design, and operation itself, serve to constrain the process and to define the Windows of Operation. The insight gained from the case study provides a useful indication of the utility of the methodology presented and illustrates the challenges of centrifuge selection for the demanding case of high solids concentration feed streams.

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The use of windows of operation as a bioprocess design tool

Cited by 33 publications

References 0 publications

Advances in Enzyme Technology — UK Contributions

Advances in Enzyme Technology — UK Contributions

Global sensitivity analysis for the determination of parameter importance in the chromatographic purification of polyclonal antibodies

A methodology for centrifuge selection for the separation of high solids density cell broths by visualisation of performance using windows of operation

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