Expediting the chromatographic analysis of COVID-19 antibody therapeutics with ultra-short columns, retention modeling and automated method development

Duivelshof, Bastiaan L.; Zöldhegyi, Arnold; Guillarme, Davy; Lauber, Matthew; Fekete, Szabolcs

doi:10.1016/j.jpba.2022.115039

Cited by 11 publications

(2 citation statements)

References 34 publications

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“…To expedite the chromatographic analysis of casirivimab and imdevimab, ultra-short columns, retention modeling, and automated method development have been successfully used for characterizing these antibodies. 117 As an example, the development and verification of four complementary analytical methods required only 2 days of experimental work and a comprehensive characterization of the mAb cocktail by four different profiling techniques was achieved within a one-hour turnaround time.…”

Section: Implementing Advanced Analytical Methodsmentioning

confidence: 99%

Effects of the COVID-19 pandemic: new approaches for accelerated delivery of gene to first-in-human CMC data for recombinant proteins

Broly

Souquet

Beck

2023

mAbs

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The COVID-19 pandemic highlighted the urgent need for life-saving treatments, including vaccines, drugs, and therapeutic antibodies, delivered at unprecedented speed. During this period, recombinant antibody research and development cycle times were substantially shortened without compromising quality and safety, thanks to prior knowledge of Chemistry, Manufacturing and Controls (CMC) and integration of new acceleration concepts discussed below. Early product knowledge, selection of a parental cell line with appropriate characteristics, and the application of efficient approaches for generating manufacturing cell lines and manufacturing drug substance from non-clonal cells for preclinical and first-in-human studies are key elements for success. Prioritization of established manufacturing and analytical platforms, implementation of advanced analytical methods, consideration of new approaches for adventitious agent testing and viral clearance studies, and establishing stability claim with less real-time data are additional components that enable an accelerated successful gene to clinical-grade material development strategy.

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Section: Implementing Advanced Analytical Methodsmentioning

confidence: 99%

Effects of the COVID-19 pandemic: new approaches for accelerated delivery of gene to first-in-human CMC data for recombinant proteins

Broly

Souquet

Beck

2023

mAbs

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“…The DryLab software package relies on fundamental chromatographic theories, such as the solvophobic theory described by Csaba Horváth and Imre Molnár [27,28] and LSSM [29], alongside the experimental design-based framework for chromatographic retention predictions. The software is widely applied mostly for modeling reverse-phase separation processes [24,[30][31][32][33][34], but is also useful for the optimization of ion-exchange chromatography (IEX) [35], hydrophobic interaction chromatography (HIC), and hydrophobic interaction liquid chromatography (HILIC) [8,36,37]. Consequently, the utilization of this widely recognized theoretical model in the software enables accurate anticipation of the chromatographic performance of analytes in reverse-phase mode.…”

Section: Introductionmentioning

confidence: 99%

The Applicability of Chromatographic Retention Modeling on Chiral Stationary Phases in Reverse-Phase Mode: A Case Study for Ezetimibe and Its Impurities

Ferencz,

Kelemen,

Obreja

et al. 2023

IJMS

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Mechanistic modeling is useful for predicting and modulating selectivity even in early chromatographic method development. This approach is also in accordance with current analytical quality using design principles and is highly welcomed by the authorities. The aim of this study was to investigate the separation behavior of two different types of chiral stationary phases (CSPs) for the separation of ezetimibe and its related substances using the mechanistic retention modeling approach offered by the Drylab software (version 4.5) package. Based on the obtained results, both CSPs presented with chemoselectivity towards the impurities of ezetimibe. The cyclodextrin-based CSP displayed a higher separation capacity and was able to separate seven related substances from the active pharmaceutical ingredient, while the cellulose-based column enabled the baseline resolution of six impurities from ezetimibe. Generally, the accuracy of predicted retention times was lower for the polysaccharide CSP, which could indicate the presence of additional secondary interactions between the analytes and the CSP. It was also demonstrated that the combination of mechanistic modeling and an experimental design approach can be applied to method development on CSPs in reverse-phase mode. The applicability of the methods was tested on spiked artificial placebo samples, while intraday and long-term (2 years) method repeatability was also challenged through comparing the obtained retention times and resolution values. The results indicated the excellent robustness of the selected setpoints. Overall, our findings indicate that the chiral columns could offer orthogonal selectivity to traditional reverse-phase columns for the separation of structurally similar compounds.

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Greening Separation and Purification of Proteins and Peptides

Maráková

2024

J of Separation Science

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The increasing awareness of environmental issues and the transition to green analytical chemistry (GAC) have gained popularity among academia and industry in recent years. One of the principles of GAC is the reduction and replacement of toxic solvents with more sustainable and environmentally friendly ones. This review gives an overview of the advances in applying green solvents as an alternative to the traditional organic solvents for peptide and protein purification and analysis by liquid chromatography (LC) and capillary electrophoresis (CE) methods. The feasibility of using greener LC and CE methods is demonstrated through several application examples; however, there is still plenty of room for new developments to fully realize their potential and to address existing challenges. Thanks to the tunable properties of designer solvents, such as ionic liquids and deep eutectic solvents, and almost infinite possible mixtures of components for their production, it is possible that some new designer solvents could potentially surpass the traditional harmful solvents in the future. Therefore, future research should focus mainly on developing new solvent combinations and enhancing analytical instruments to be able to effectively work with green solvents.

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Expediting the chromatographic analysis of COVID-19 antibody therapeutics with ultra-short columns, retention modeling and automated method development

Cited by 11 publications

References 34 publications

Effects of the COVID-19 pandemic: new approaches for accelerated delivery of gene to first-in-human CMC data for recombinant proteins

Effects of the COVID-19 pandemic: new approaches for accelerated delivery of gene to first-in-human CMC data for recombinant proteins

The Applicability of Chromatographic Retention Modeling on Chiral Stationary Phases in Reverse-Phase Mode: A Case Study for Ezetimibe and Its Impurities

Greening Separation and Purification of Proteins and Peptides

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