High-Resolution Native Mass Spectrometry

Chemical Reviews, Journal Year: 2021, Volume and Issue: 122(8), P. 7269 - 7326

Published: Aug. 20, 2021

Native mass spectrometry (MS) involves the analysis and characterization of macromolecules, predominantly intact proteins protein complexes, whereby as much possible native structural features analytes are retained. As such, MS enables study secondary, tertiary, even quaternary structure other biomolecules. represents a relatively recent addition to analytical toolbox has over past decade experienced immense growth, especially in enhancing sensitivity resolving power but also ease use. With advent dedicated analyzers, sample preparation separation approaches, targeted fragmentation techniques, software solutions, number practitioners novel applications risen both academia industry. This review focuses on developments, particularly high-resolution MS, describing assemblies, proteoform profiling of─among others─biopharmaceuticals plasma proteins, quantitative qualitative protein-ligand interactions, with latter covering lipid, drug, carbohydrate molecules, name few.

Language: Английский

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Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies

Pharmaceuticals, Journal Year: 2023, Volume and Issue: 16(2), P. 291 - 291

Published: Feb. 14, 2023

Monoclonal antibodies (mAbs) are a fast-growing class of biopharmaceuticals. They widely used in the identification and detection cell makers, serum analytes, pathogenic agents, remarkably for cure autoimmune diseases, infectious or malignancies. The successful application therapeutic mAbs is based on their ability to precisely interact with appropriate target sites. precision rely isolation techniques delivering pure, consistent, stable, safe lots that can be analytical, diagnostic, applications. During creation biologic, key quality features particular mAb, such as structure, post-translational modifications, activities at biomolecular cellular levels, must characterized profiled great detail. This implies requirement powerful state art analytical control characterization mAbs. Until now, various have been developed characterize quantify according regulatory guidelines. present review summarizes major analyses which include chromatographic, electrophoretic, spectroscopic, electrochemical methods addition modifications these improving compilation will help students researchers an overview methodologies employed by biopharmaceutical industry structural eventual release therapeutics drug market.

Language: Английский

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Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms

Frontiers in Bioengineering and Biotechnology, Journal Year: 2022, Volume and Issue: 10

Published: Feb. 9, 2022

Biopharmaceuticals are one of the fastest-growing sectors in biotechnology industry. Within umbrella biopharmaceuticals, biosimilar segment is expanding with currently over 200 approved biosimilars, globally. The key step towards achieving a successful approval to establish analytical and clinical biosimilarity innovator. objective an study demonstrate highly similar profile respect variations critical quality attributes (CQAs) product, these must lie within range set by This comprises detailed comparative structural functional characterization using appropriate, validated methods fingerprint molecule helps reduce economic burden regulatory requirement extensive preclinical/clinical similarity data, thus making biotechnological drugs more affordable. In last decade, manufacturing associated regulations have become established, leading numerous approvals. Biosimilarity assessment exercises conducted also published frequently public domain. Consequently, some technical advancements sciences percolated applications assessment. Keeping this mind, review aims at providing holistic view progresses analysis approval. review, we summarized major developments global landscape approvals catalogued studies for recombinant DNA products available We covered recent methods, orthogonal techniques, platforms characterization, since 2015. specifically serve as comprehensive catalog details on platform used multiple biotherapeutic products. Through compilation, emergent evolution techniques each CQA has been charted discussed. Lastly, information resource studies, created during literature search anticipated helpful reference biopharmaceutical scientists developers.

Language: Английский

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Capillary electrophoresis‐mass spectrometry for intact protein analysis: Pharmaceutical and biomedical applications (2018–March 2023)

Journal of Separation Science, Journal Year: 2023, Volume and Issue: 46(15)

Published: May 26, 2023

Capillary electrophoresis is recognized as a valued separation technique for its high efficiency, low sample consumption, good economic and ecological aspects, reproducibility, complementarity to traditional liquid chromatography techniques. experiments are generally performed utilizing optical detection, such ultraviolet or fluorescence detectors. However, in order provide structural information, capillary hyphenated highly sensitive selective mass spectrometry has been developed overcome the limitations of detections. electrophoresis‐mass increasingly popular protein analysis, including biopharmaceutical biomedical research. It frequently applied determination physicochemical biochemical parameters proteins, offers excellent performance in‐depth characterizations biopharmaceuticals at various levels also already proven promising tool biomarker discovery. In this review, we focus on possibilities analysis their intact level. Various modes interfaces, well approaches prevent adsorption enhance loading capacity, discussed recent (2018–March 2023) developments applications field summarized.

Language: Английский

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Capillary electrophoresis‐mass spectrometry for protein analyses under native conditions: Current progress and perspectives

PROTEOMICS, Journal Year: 2023, Volume and Issue: 24(3-4)

Published: June 13, 2023

Abstract Native mass spectrometry is a rapidly emerging technique for fast and sensitive structural analysis of protein constructs, maintaining the higher order structure. The coupling with electromigration separation techniques under native conditions enables characterization proteoforms highly complex mixtures. In this review, we present an overview current CE‐MS technology. First, status described capillary zone electrophoresis (CZE), affinity (ACE), isoelectric focusing (CIEF), as well their chip‐based formats, including essential parameters such electrolyte composition coatings. Further, required ESI‐MS (large) instrumental QTOF Orbitrap systems, requirements interfacing are presented. On basis, methods applications different modes summarized discussed in context biological, medical, biopharmaceutical questions. Finally, key achievements highlighted concluded, while remaining challenges pointed out.

Language: Английский

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Current green capillary electrophoresis and liquid chromatography methods for analysis of pharmaceutical and biomedical samples (2019–2023) – A review

Analytica Chimica Acta, Journal Year: 2024, Volume and Issue: 1323, P. 342889 - 342889

Published: June 20, 2024

Separation analytical methods, including liquid chromatography (LC) and capillary electrophoresis (CE), in combination with an appropriate detection technique, are dominant powerful approaches preferred the analysis of pharmaceutical biomedical samples. Recent trends methods focused on activities that push them to field greenness sustainability. New based implementation greener solvents, non-hazardous chemicals, reagents have grown exponentially. Similarly, recent pushed strategies miniaturization, reduction wastes, avoiding derivatization procedures, or energy consumption. However, real method can be evaluated only according objective sufficient metric offering complex results taking into account all twelve rules green chemistry (SIGNIFICANCE mnemonic system). This review provides extensive overview papers published area development LC CE over last 5 years (2019-2023). The main focus is situated metrics used for evaluation applied determination bioactive agents. It critically evaluates compares demands applicability quality control clinical environment requirements (GAC). Greenness practicality summarized re-evaluated newly use tools, i.e., Analytical GREEnness (AGREE), Green Procedure Index (GAPI), Blue Applicability Grade (BAGI), Sample Preparation Metric Sustainability (SPMS). Moreover, general conclusions future perspectives greening procedures systems presented. paper should provide comprehensive information chemists, biochemists, it also represent a valuable source clinicians, laboratories interested greenness, practicality,

Language: Английский

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Denaturing and Native Mass Spectrometric Analytics for Biotherapeutic Drug Discovery Research: Historical, Current, and Future Personal Perspectives

Journal of the American Society for Mass Spectrometry, Journal Year: 2021, Volume and Issue: 32(8), P. 1861 - 1885

Published: April 22, 2021

Mass spectrometry (MS) plays a key role throughout all stages of drug development and is now as ubiquitous other analytical techniques such surface plasmon resonance, nuclear magnetic supercritical fluid chromatography, among others. Herein, we aim to discuss the history MS, both electrospray matrix-assisted laser desorption ionization, specifically for analysis antibodies, evolving through denaturing native-MS newer biologic moieties antibody–drug conjugates, multispecific interfering nucleic acid–based therapies. We challenging therapeutic target characterization membrane protein receptors. Importantly, compare contrast MS hyphenated chromatographic methods used characterize these modalities targets within biopharmaceutical research highlight importance appropriate deconvolution software its essential contribution project progression. Finally, describe emerging applications technologies that are still predominantly either or academic stage use but poised have significant impact on future biopharmaceutic industry once matured. The views reflected herein personal not meant be an exhaustive list relevant performed what feel been historically, currently, will in most impactful process.

Language: Английский

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N-Glycosylation of monoclonal antibody therapeutics: A comprehensive review on significance and characterization

Analytica Chimica Acta, Journal Year: 2022, Volume and Issue: 1209, P. 339828 - 339828

Published: April 13, 2022

Language: Английский

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Analysis of Monoclonal Antibodies by Capillary Electrophoresis: Sample Preparation, Separation, and Detection

Separations, Journal Year: 2021, Volume and Issue: 8(1), P. 4 - 4

Published: Jan. 4, 2021

Therapeutic monoclonal antibodies (mAbs) are dominating the biopharmaceutical field due to fact of their high specificity in treatment diverse diseases. Nevertheless, mAbs very complex glycoproteins exhibiting several macro- and microheterogeneities that may affect safety, quality, efficacy. This complexity is challenging for development, formulation, quality control. To tackle issue, a combination multiple analytical approaches necessary. In this perspective, capillary electrophoresis has gained considerable interest over last decade its complementary features chromatographic approaches. review provides an overview strategies derivatives analysis by hyphenated ultraviolet, fluorescence, mass spectrometry detection. The main sample preparation used mAb characterization (i.e., intact, middle-up/down, bottom-up) detailed. different electrophoretic modes as well integrated (sample separation) critically discussed.

Language: Английский

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Applications of capillary electrophoresis for biopharmaceutical product characterization

Electrophoresis, Journal Year: 2021, Volume and Issue: 43(1-2), P. 143 - 166

Published: Sept. 30, 2021

Capillary electrophoresis (CE), after being introduced several decades ago, has carved out a niche for itself in the field of analytical characterization biopharmaceutical products. It does not only offer fast separation, high resolution miniaturized format, but equally importantly represents an orthogonal separation mechanism to high-performance liquid chromatography. Therefore, it is surprising that CE-based methods can be found all major pharmacopoeias and are recommended analysis products during process development, characterization, quality control, release testing. Different formats CE, such as capillary gel electrophoresis, isoelectric focusing, zone widely used size charge heterogeneity well purity stability testing therapeutic proteins. Hyphenation CE with MS emerging promising bioanalytical tool assess primary structure proteins along any impurities. In this review, we confer latest developments critical attributes covering past 6 years (2015-2021). Monoclonal antibodies, due their significant share market, have been given prioritized coverage.

Language: Английский

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