Green Analytical Chemistry, Год журнала: 2025, Номер unknown, С. 100204 - 100204
Опубликована: Янв. 1, 2025
Язык: Английский
Процитировано
2
Journal of Chromatography A, Год журнала: 2024, Номер 1736, С. 465353 - 465353
Опубликована: Сен. 8, 2024
Язык: Английский
Процитировано
5
Electrophoresis, Год журнала: 2024, Номер unknown
Опубликована: Сен. 30, 2024
ABSTRACT Native mass spectrometry (nMS) is a cutting‐edge technique that leverages electrospray ionization MS (ESI‐MS) to investigate large biomolecules and their complexes in solution. The goal of nMS retain the native structural features interactions analytes during transition gas phase, providing insights into natural conformations. In biopharmaceutical development, serves as powerful tool for analyzing complex protein heterogeneity, allowing examination non‐covalently bonded assemblies state closely resembles folded form. Herein, we present an imaged capillary isoelectric focusing–MS (icIEF–MS) workflow characterize cysteine‐linked antibody–drug conjugate (ADC) under conditions. Two ADCs were analyzed: latest generation ADC polatuzumab vedotin first FDA‐approved brentuximab vedotin. This benefits from recently developed icIEF system MS‐friendly capable directly coupling high‐sensitivity instrument. Results show separation influenced by both drug payloads post‐translational modifications (PTMs), which are then promptly identified MS. Overall, this icIEF–MS method demonstrates potential understand control critical quality attributes (CQAs) essential safe effective use ADCs.
Язык: Английский
Процитировано
5
Frontiers in Chemistry, Год журнала: 2025, Номер 13
Опубликована: Фев. 20, 2025
Biopharmaceuticals are increasingly utilised in the treatment of oncological, inflammatory, and autoimmune diseases, largely due to their exceptional specificity targeting antigens. However, structural complexity, heterogeneity, sensitivity pose crucial challenges production, purification, delivery. Charge heterogeneity analysis, a Critical Quality Attribute these biomolecules used Control, is often performed using separative analytical techniques such as imaged capillary Isoelectric Focusing (icIEF). Recognized gold standard by industry, icIEF leverages pH gradient provide high-resolution profiling charge variants biotherapeutics. In this review, critical experimental parameters for method development context biotherapeutic drug QC will be discussed. Key aspects, including sample preparation, properties, carrier ampholytes, stabilizers, detection examined, supported recent literature. Advances technology its expanding applications underline robustness, reproducibility, compliance with regulatory standards, affirming pivotal role ensuring identity consistency biological products.
Язык: Английский
Процитировано
0
TrAC Trends in Analytical Chemistry, Год журнала: 2025, Номер unknown, С. 118212 - 118212
Опубликована: Фев. 1, 2025
Язык: Английский
Процитировано
0
Analytical Biochemistry, Год журнала: 2025, Номер 701, С. 115825 - 115825
Опубликована: Март 2, 2025
Язык: Английский
Процитировано
0
Опубликована: Янв. 1, 2024
Язык: Английский
Процитировано
0
Green Analytical Chemistry, Год журнала: 2024, Номер 10, С. 100122 - 100122
Опубликована: Июнь 25, 2024
This article has been retracted: Please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/locate/withdrawalpolicy). retracted at the request of authors. The manuscript was submitted before a final round revision by As result, not all authors had opportunity to review and approve it, there are series errors that should have rectified prior publication. These are: • Some figures do contain reference original source (permissions obtained reproduce but this properly represented). sentences in Introduction were taken verbatim from other sources while no included source. need further supplement some data discussion improve paper. apologise for error.
Язык: Английский
Процитировано
0
Опубликована: Янв. 1, 2024
Язык: Английский
Процитировано
0