Identifying analytics for high throughput bioprocess development studies

Konstantinidis, Spyridon; Kong, Simyee; Titchener‐Hooker, Nigel J.

doi:10.1002/bit.24850

Cited by 17 publications

(12 citation statements)

References 73 publications

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“…Development of high-throughput analytical methods and frameworks would help alleviate some existing bottlenecks in the characterization process [209]. Early prediction of production level and product aggregation can be performed by selecting clones LC:HC mRNA ratios above 1.5 [93].…”

Section: Key Termsmentioning

confidence: 99%

Generation of monoclonal antibody-producing mammalian cell lines

Ho¹,

Yang²

2013

Pharmaceutical Bioprocessing

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Section: Key Termsmentioning

confidence: 99%

Generation of monoclonal antibody-producing mammalian cell lines

Ho¹,

Yang²

2013

Pharmaceutical Bioprocessing

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“…In such an approach, however, a large number of conditions may be tested, especially when the number of investigated factors is large. As a result a relatively large amount of material may be consumed, which could be limiting in early process development, and a large number of samples may need to be analyzed, which can be expensive and lengthy …”

Section: Introductionmentioning

confidence: 99%

Application of simplex‐based experimental optimization to challenging bioprocess development problems: Case studies in downstream processing

Konstantinidis

Welsh

Roush

et al. 2016

Biotechnology Progress

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The identification of feasible operating conditions during the early stages of bioprocess development is implemented frequently through High Throughput (HT) studies. These typically employ techniques based on regression analysis, such as Design of Experiments. In this work, an alternative approach, based on a previously developed variant of the Simplex algorithm, is compared to the conventional regression-based method for three experimental systems involving polishing chromatography and protein refolding. This Simplex algorithm variant was found to be more effective in identifying superior operating conditions, and in fact it reached the global optimum in most cases involving multiple optima. By contrast, the regression-based method often failed to reach the global optimum, and in many cases reached poor operating conditions. The Simplex-based method is further shown to be robust in dealing with noisy experimental data, and requires fewer experiments than regression-based methods to reach favorable operating conditions. The Simplex-variant also lends itself to the use of HT analytical methods, when they are available, which can assist in avoiding analytical bottlenecks. It is suggested that this Simplex-variant is ideally suited to rapid optimization in early-phase process development. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:404-419, 2016.

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“…The techniques used to assess these parameters have developed rapidly over the last decade reducing sample requirements and becoming higher throughput [32]. As a result of this, HTP methods can act as an input for many analytical tools, with protein A or other affinity-based purification often used in filter plates.…”

Section: -Well Filter Plate Purificationmentioning

confidence: 99%

Current advances in the development of high-throughput purification strategies for the generation of therapeutic antibodies

Spooner¹,

Wilkinson²,

Kemp³

2015

Pharmaceutical Bioprocessing

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The demand for therapeutic proteins, and particularly monoclonal antibodies, continues to grow within the biopharmaceutical industry. This is illustrated by the monoclonal antibody Humira ® (adalimumab) having the highest sales of any drug in 2014. With the increasing numbers of biologics entering the market and the emergence of biosimilars and biobetters, costs need to be reduced in order for companies to remain competitive. High-throughput purification can provide the tools to meet the challenge of producing the thousands of potential drug candidates generated in drug discovery while simultaneously providing robust and cost-effective purification strategies in both research and production. In this review, we discuss the many different methodologies and automation technologies that can be employed in high-throughput purification.

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Identifying analytics for high throughput bioprocess development studies

Cited by 17 publications

References 73 publications

Generation of monoclonal antibody-producing mammalian cell lines

Generation of monoclonal antibody-producing mammalian cell lines

Application of simplex‐based experimental optimization to challenging bioprocess development problems: Case studies in downstream processing

Current advances in the development of high-throughput purification strategies for the generation of therapeutic antibodies

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