Risk–benefit evaluation of on-line high-performance liquid chromatography analysis for pooling decisions in large-scale chromatography

Kaltenbrunner, Oliver; Lu, Yihuan; Sharma, Ashutosh; Lawson, Ken; Tressel, Tim

doi:10.1016/j.chroma.2012.04.003

Cited by 25 publications

(25 citation statements)

References 14 publications

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“…Cumulative infiltration and the time for runoff generation have been reported to decrease as gradients increased, and the gradient positively influenced runoff coefficients and sediment concentrations (Chamizo et al, 2012). The size of the area affected by rain and other experimental conditions can also influence simulated soil erosion (Wang et al, 2009;Chamizo et al, 2012;Kaltenbrunner et al, 2012). Mean sediment yield, simulated in a soil box, was negatively correlated with slope gradients 25°-30° ( Wang et al, 2005).…”

Section: Introductionmentioning

confidence: 93%

Simulated erosion using soils from vegetated slopes in the Jiufeng Mountains, China

Sun

et al. 2016

CATENA

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Section: Introductionmentioning

confidence: 93%

Simulated erosion using soils from vegetated slopes in the Jiufeng Mountains, China

Sun

et al. 2016

CATENA

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“…An HPLC based method has been demonstrated to be more reliable and specific than the traditional offline HPLC. This was verified both at pilot scale (30 cm diameter chromatography column) and large scale (120 cm diameter) . Stopped flow analysis has also been used as an at‐line tool to provide a visual description of product levels and real‐time representation of yield during the production of alcohol dehydrogenase via hydrophobic interaction chromatography (HIC) in Saccharomyces cerevisiae .…”

Section: Recent Advances In Implementation Of Pat Towards Downstream mentioning

confidence: 89%

“…From the case studies mentioned above, it is evident that several analytical tools for implementation of PAT for process chromatography have been developed. So far, adoption of PAT in the industry has been sparse but we think that for cases when baseline separation cannot be achieved and when the product is a high volume product, significant productivity enhancement can be achieved by implementation of PAT …”

Section: Recent Advances In Implementation Of Pat Towards Downstream mentioning

confidence: 99%

Application of process analytical technology for downstream purification of biotherapeutics

Rathore

Kapoor

2014

J of Chemical Tech & Biotech

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The concept of Process Analytical Technology (PAT) introduced by the US FDA has received a lot of attention lately. The use of such a scheme ensures robust process performance over the entire life cycle of the product and consistent product quality at the end of the manufacturing process. Successful implementation of PAT requires use of high resolution, orthogonal analytical tools that are able to measure the critical quality attributes (CQA) of the raw materials and in‐process materials with the aim of ensuring final product quality. This article presents a review of PAT applications for monitoring commonly used downstream biotech unit operations. Focus of the review will be on recent advancements (last 5 years). Analytical tools that have been used in these approaches have also been discussed with reference to their speed of analysis, robustness and sensitivity. Also discussed is their potential to replace the traditional high performance liquid chromatography (HPLC) which continues to be the gold standard for analysis of biotech therapeutics. © 2014 Society of Chemical Industry

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“…With this study, we demonstrated the proof of principle that an online sensor array combined with PLS modeling can be used for the prediction of multiple quality parameters during a preparative chromatography run. Other studies dealing with online monitoring of an antibody capture process have been published using only one online sensor . Großhans et al separated an antibody from lysozyme with a cation exchanger and predicted the elution behavior via an FTIR detector yielding an RMSE of prediction of the antibody concentration of 2.42 g L −1 (max.…”

Section: Discussionmentioning

confidence: 99%

“…Actions in DSP have to be placed within seconds, and the measurement has to be suitably fast. At‐line high‐performance liquid chromatography (HPLC) measurements were proposed by different research groups . However, such HPLC measurements require automated sampling and subsequent data analyses to obtain results fast enough to give feedback information.…”

Section: Introductionmentioning

confidence: 99%

Prediction of the Quantity and Purity of an Antibody Capture Process in Real Time

Walch

Scharl

Felföldi

et al. 2019

Biotechnology Journal

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Regulatory recommendations for quality by design instead of quality by testing raise increasing interest in new sensor technologies. An online monitoring system for downstream processes is developed, which is based on an array of online detectors. Besides standard detectors (UV, pH, and conductivity), our chromatographic workstation is equipped with a fluorescence and a mid‐infrared spectrometer, a light scattering, and a refractive index detector. The combination of these sensors enables the prediction of specific protein concentration and various purity attributes, such as high molecular weight impurities, DNA and host cell protein content during the elution phase of a chromatographic antibody capture process. Prediction models solely based on online signals are set up providing real‐time predictions. No mechanistic models or information about the chromatographic runs is used. These predictions allow online pooling decisions replacing time‐ and labor‐intensive laboratory measurements. Different process variations, such as changes in the column load or elution buffer, are introduced to test the predictive power of the models. Extrapolation of the models worked well when the column load is changed, whereas model adjustment is necessary when the elution conditions are changed considerably.

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Risk–benefit evaluation of on-line high-performance liquid chromatography analysis for pooling decisions in large-scale chromatography

Cited by 25 publications

References 14 publications

Simulated erosion using soils from vegetated slopes in the Jiufeng Mountains, China

Simulated erosion using soils from vegetated slopes in the Jiufeng Mountains, China

Application of process analytical technology for downstream purification of biotherapeutics

Prediction of the Quantity and Purity of an Antibody Capture Process in Real Time

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