The versatility of heart-cutting and comprehensive two-dimensional liquid chromatography in monoclonal antibody clone selection

Sandra, Koen; Steenbeke, Mieke; Vandenheede, Isabel; Vanhoenacker, Gerd; Sandra, Pat

doi:10.1016/j.chroma.2017.06.052

Cited by 63 publications

(49 citation statements)

References 34 publications

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“…Intact mass has the advantage over other middle down and peptide mapping approaches in that no sample preparation is required, thus allowing proteoform heterogeneity to be assessed at the intact level. It has been applied during clonal selection, process optimization, and as a component of analytical similarity assessments 22-24 . HRMS was therefore selected as an efficient method to compare the RM 8671 and the non-originator products with respect to major glycoforms and moderate to high abundance primary sequence modifications.…”

Section: Resultsmentioning

confidence: 99%

Heterologous recombinant expression of non-originator NISTmAb

Kashi

Yandrofski

Preston

et al. 2018

mAbs

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The successful development and regulatory approval of originator and biosimilar therapeutic proteins requires a systems approach to upstream and downstream processing as well as product characterization and quality control. Innovation in process design and control, product characterization strategies, and data integration represent an ecosystem whose concerted advancement may reduce time-to-market and further improve comparability and biosimilarity programs. The biopharmaceutical community has made great strides to this end, yet there currently exists no pre-competitive monoclonal antibody (mAb) expression platform for open innovation. Here, we describe the development and initial expression of an intended copy of the NISTmAb using three non-originator murine cell lines. It was found that, without optimization and in culture flasks, all three cell lines produce approximately 100 mg mAb per liter of culture. Sodium dodecyl sulfate polyacrylamide gel electrophoresis, size-exclusion chromatography, nuclear magnetic resonance spectroscopy, intact mass spectrometry, and surface plasmon resonance were used to demonstrate that the products of all three cell lines embody quality attributes with a sufficient degree of sameness to the NISTmAb Reference Material 8671 to warrant further bioreactor studies, process improvements and optimization. The implications of the work with regard to pre-competitive innovation to support process design and feedback control, comparability and biosimilarity assessments, and process analytical technologies are discussed.

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Section: Resultsmentioning

confidence: 99%

Heterologous recombinant expression of non-originator NISTmAb

Kashi

Yandrofski

Preston

et al. 2018

mAbs

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“…Automated cell‐free sampling devices such as the MAST® or Seg‐flow® are required to operate 2D‐LC systems as on‐line monitoring technologies. Williams and coworkers report an automated 2D‐LC method for characterization of protein aggregation with an in‐line fraction collection device (Sandra, Steenbeke, Vandenheede, Vanhoenacker, & Sandra, 2017). In certain instances, the technology has been coupled with mass spectrometers for further characteristic understanding of the chromatographic peaks (Petersson, Haselmann, & Buckenmaier, 2016; Stoll, Danforth, Zhang, & Beck, 2016).…”

Section: Process Analytical Technologiesmentioning

confidence: 99%

Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

Wasalathanthri

Rehmann

Song

et al. 2020

Biotech & Bioengineering

113

101

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Real‐time monitoring of bioprocesses by the integration of analytics at critical unit operations is one of the paramount necessities for quality by design manufacturing and real‐time release (RTR) of biopharmaceuticals. A well‐defined process analytical technology (PAT) roadmap enables the monitoring of critical process parameters and quality attributes at appropriate unit operations to develop an analytical paradigm that is capable of providing real‐time data. We believe a comprehensive PAT roadmap should entail not only integration of analytical tools into the bioprocess but also should address automated‐data piping, analysis, aggregation, visualization, and smart utility of data for advanced‐data analytics such as machine and deep learning for holistic process understanding. In this review, we discuss a broad spectrum of PAT technologies spanning from vibrational spectroscopy, multivariate data analysis, multiattribute chromatography, mass spectrometry, sensors, and automated‐sampling technologies. We also provide insights, based on our experience in clinical and commercial manufacturing, into data automation, data visualization, and smart utility of data for advanced‐analytics in PAT. This review is catered for a broad audience, including those new to the field to those well versed in applying these technologies. The article is also intended to give some insight into the strategies we have undertaken to implement PAT tools in biologics process development with the vision of realizing RTR testing in biomanufacturing and to meet regulatory expectations.

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“…It allowed the detection for the first time of a glycosylated form of ApoA-I in human in vivo samples. More recently, a heart-cutting 2D-LC set up combining protein A with RPLC-MS was used to select mAb producing clones based on glycosylation [122]. Once again, the RPLC column was mainly used for desalting.…”

Section: Other Lc Modesmentioning

confidence: 99%

Separation methods hyphenated to mass spectrometry for the characterization of the protein glycosylation at the intact level

Camperi

Pichon

Delaunay

2020

Journal of Pharmaceutical and Biomedical Analysis

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Glycosylation is one of the most common post-translational modifications of proteins that affects their biological activity, solubility, and half-life. Therefore, its characterization is of great interest in proteomic, particularly from a diagnostic and therapeutic point of view. However, the number and type of glycosylation sites, the degree of site occupancy and the different possible structures of glycans can lead to a very large number of isoforms for a given protein, called glycoforms. The identification of these glycoforms constitutes an important analytical challenge. Indeed, to attempt to characterize all of them, it is necessary to develop the development and optimization of the separation step to achieve high resolution between isoforms, the recent ones are much more application-oriented, such as clinical diagnosis, quality control, and glycoprotein monitoring in formulations or biological samples.

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The versatility of heart-cutting and comprehensive two-dimensional liquid chromatography in monoclonal antibody clone selection

Cited by 63 publications

References 34 publications

Heterologous recombinant expression of non-originator NISTmAb

Heterologous recombinant expression of non-originator NISTmAb

Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

Separation methods hyphenated to mass spectrometry for the characterization of the protein glycosylation at the intact level

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