Optimization of a preparative multimodal ion exchange step for purification of a potential malaria vaccine

Paul, Jessica; Jensen, Sonja; Dukart, Arthur; Cornelissen, Gesine

doi:10.1016/j.chroma.2014.09.029

Cited by 16 publications

(5 citation statements)

References 17 publications

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“…Nowadays, DOE is widely used in all areas of science where new information can be obtained through experimental tests of various combinations of parameter settings (factors) and their influence on the results (responses). The applications range from product development, process optimization, , quality control, and robustness testing to practical applications in analytical chemistry such as optimization of chromatographic conditions to ensure the best method performance, , optimization of LC-MS data processing in metabolomics, and optimization of protocols for 96-well plate analysis …”

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confidence: 99%

Generalized Subset Designs in Analytical Chemistry

et al. 2017

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Design of experiments (DOE) is an established methodology in research, development, manufacturing, and production for screening, optimization, and robustness testing. Two-level fractional factorial designs remain the preferred approach due to high information content while keeping the number of experiments low. These types of designs, however, have never been extended to a generalized multilevel reduced design type that would be capable to include both qualitative and quantitative factors. In this Article we describe a novel generalized fractional factorial design. In addition, it also provides complementary and balanced subdesigns analogous to a fold-over in two-level reduced factorial designs. We demonstrate how this design type can be applied with good results in three different applications in analytical chemistry including (a) multivariate calibration using microwave resonance spectroscopy for the determination of water in tablets, (b) stability study in drug product development, and (c) representative sample selection in clinical studies. This demonstrates the potential of generalized fractional factorial designs to be applied in many other areas of analytical chemistry where representative, balanced, and complementary subsets are required, especially when a combination of quantitative and qualitative factors at multiple levels exists.

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confidence: 99%

Generalized Subset Designs in Analytical Chemistry

et al. 2017

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“…Table I shows some selected papers and its remarks about QbD application in Pharmaceutical industry, Industrial purposes and Optimization using DoE. [96][97][98][99][100][101][102][103][104][105][106][107][108] DoEs have been used in these biotechnological processes for some years, as reported by Mandenius et al [109] in a review paper, in which DoEs are a powerful tool for the optimization of bioprocesses.…”

Section: Quality By Design (Qbd) Design Of Space and Design Of Expermentioning

confidence: 99%

Key information related to quality by design (QbD) applications in analytical methods development

Araujo¹,

Andrade²,

Babos³

et al. 2020

Braz. J. Anal. Chem.

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In this review, quality by design (QbD) initiatives are described as applications for many types of processes, such as in the pharmaceutical industry, biotechnology field, and for analytical methods development. Design space (DS) and design of experiments (DoE) provide useful results for analytical methods development and simulation of advanced processes in traditional manufacturing relationships. The three topics, QbD, DS and DoE are the best way to achieve strong and efficient industrial production.

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“…The intermediate product is purified using an IMAC column which is previously charged with nickel ions (Paul et al, 2014). 15 mM imidazole is added to the product solution which is subsequently approached to the column at 5 mL min −1 flow rate.…”

Section: Downstream Unit Operationsmentioning

confidence: 99%

“…Different methods like two stage elution of IMAC and multimodal ion exchange are optimized with DoE in an AEKTA TM avant chromatography system (Paul et al, 2014).…”

Section: Previous Investigations In Recombinant Protein Production Anmentioning

confidence: 99%

Sequential/parallel production of potential Malaria vaccines – A direct way from single batch to quasi-continuous integrated production

Luttmann

Borchert

Mueller

et al. 2015

Journal of Biotechnology

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Optimization of a preparative multimodal ion exchange step for purification of a potential malaria vaccine

Cited by 16 publications

References 17 publications

Generalized Subset Designs in Analytical Chemistry

Generalized Subset Designs in Analytical Chemistry

Key information related to quality by design (QbD) applications in analytical methods development

Sequential/parallel production of potential Malaria vaccines – A direct way from single batch to quasi-continuous integrated production

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