Simulated Moving Bed (SMB): Some Possible Applications for Biotechnology

Nicoud, Roger‐Marc

doi:10.1002/9783527619641.ch1

Cited by 21 publications

(17 citation statements)

References 28 publications

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“…The above drawback of VEAX can be easily offset by recycling a single column or operating in multiple column mode [e.g. simulated moving bed (SMB) chromatography] with inherent advantages including the use of a smaller amount of stationary phases for chromatographic separation, continuity and high productivity, and the reduction of solvent and energy requirements …”

Section: Resultsmentioning

confidence: 99%

A seamless and nonprotein A‐based monoclonal antibody purification platform using void‐exclusion anion exchange chromatography and electropositive multimodal chromatography enhanced by advance chromatin extraction

Liu

Chen

Fan

et al. 2019

J of Chemical Tech & Biotech

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BACKGROUND Downstream production of monoclonal antibodies (mAbs) involves several complex unit operations, directly affecting whether they can be used in clinical practice. Protein A affinity chromatography is considered the de facto standard due to its ability to selectively capture antibodies from cell culture supernatant (CCS). Recent studies on various associations of host cell contaminants have shown that downstream purification can be enhanced substantially with advance chromatin removal, facilitating the development of more promising nonaffinity purification platforms. RESULTS In this study, void‐exclusion anion exchange chromatography (VEAX) was systematically characterized for its potential use as an initial antibody separation and recovery step. Void exclusion refers to a new chromatographic mode, which is different from the traditional bind‐elute and flow‐through operations. The new separation method is based on the size of the molecules as well as their surface charges. This process causes the initial immunoglobulin G (IgG) separation to become independent of sample composition (especially for pH and conductivity), eliminating the need to equilibrate the sample. Electropositive multimodal chromatography was then seamlessly incorporated with direct protein loading for further antibody polishing. With the aid of advanced chromatin removal, the two‐step purification platform achieved production of an antibody with <1 ppb DNA, <1 ppm HCP and <0.05% high‐molecular‐weight aggregates with IgG recovery of 90.4%. CONCLUSION This outcome provides a highly promising nonaffinity purification process and a competitive alternative for the current protein A‐dominated antibody processing strategy. © 2019 Society of Chemical Industry

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Section: Resultsmentioning

confidence: 99%

A seamless and nonprotein A‐based monoclonal antibody purification platform using void‐exclusion anion exchange chromatography and electropositive multimodal chromatography enhanced by advance chromatin extraction

Liu

Chen

Fan

et al. 2019

J of Chemical Tech & Biotech

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“…Several reviews have explored different possible process configurations. However, this setup has few applications in biopharmaceutical polishing steps due to two limitations. First, a four‐zone SMB can only separate binary mixtures, and second, linear gradients are not possible.…”

Section: The Polishing Stepmentioning

confidence: 99%

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

Steinebach

Müller‐Späth²,

Morbidelli

2016

Biotechnology Journal

123

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The economic advantages of continuous processing of biopharmaceuticals, which include smaller equipment and faster, efficient processes, have increased interest in this technology over the past decade. Continuous processes can also improve quality assurance and enable greater controllability, consistent with the quality initiatives of the FDA. Here, we discuss different continuous multi-column chromatography processes. Differences in the capture and polishing steps result in two different types of continuous processes that employ counter-current column movement. Continuous-capture processes are 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. In the context of continuous manufacturing, different but complementary chromatographic columns or devices are typically combined to improve overall process performance and avoid unnecessary product storage. In the following, these various processes, their performances compared with batch processing and resulting product quality are discussed based on a review of the literature. Based on various examples of applications, primarily monoclonal antibody production processes, conclusions are drawn about the future of these continuous-manufacturing technologies.

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“…This technique was originally developed by Broughton [85][86][87] to separate structurally related hydrocarbons. Whereas the technique has been used for many years in the petrochemical and sugar [88][89][90] industries, the first successful SMB enantioseparation was reported in 1992 by Negawa and Shoji (Table 21-4). It has since been used for the separation of several racemates (recently reviewed by Schulte and Strube [91]) and also for the purification of natural products obtained from fermentation processes [92].…”

Section: Simulated Moving Bed Chromatographymentioning

confidence: 99%

Trends in Preparative HPLC

Kuesters

2006

HPLC for Pharmaceutical Scientists

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Simulated Moving Bed (SMB): Some Possible Applications for Biotechnology

Cited by 21 publications

References 28 publications

A seamless and nonprotein A‐based monoclonal antibody purification platform using void‐exclusion anion exchange chromatography and electropositive multimodal chromatography enhanced by advance chromatin extraction

A seamless and nonprotein A‐based monoclonal antibody purification platform using void‐exclusion anion exchange chromatography and electropositive multimodal chromatography enhanced by advance chromatin extraction

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

Trends in Preparative HPLC

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