Post-Column Denaturation-Assisted Hydrophobic Interaction Chromatography−Mass Spectrometry for Rapid and In-Depth Characterization of Positional Isomers in Cysteine-Based Antibody-Drug Conjugates DOI

Zhengqi Zhang,

Anita P. Liu,

Hongxia Wang

et al.

Journal of Pharmaceutical and Biomedical Analysis, Journal Year: 2024, Volume and Issue: 255, P. 116635 - 116635

Published: Dec. 13, 2024

Language: Английский

An integrated protocol based on workflows of imaged capillary isoelectric focusing (icIEF) for in-depth protein heterogenous characterization: high-efficient fractionation and online mass spectrometry detection DOI Creative Commons

Teresa Kwok,

She Lin Chan,

Mike Zhou

et al.

Green Analytical Chemistry, Journal Year: 2025, Volume and Issue: unknown, P. 100204 - 100204

Published: Jan. 1, 2025

Language: Английский

Citations

2
Exploring imaged capillary isoelectric focusing parameters for enhanced charge variants quality control DOI Creative Commons

Virginia Ghizzani,

Alessandro Ascione, F. Gonnella

et al.

Frontiers in Chemistry, Journal Year: 2025, Volume and Issue: 13

Published: Feb. 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.

Language: Английский

Citations

0
Recent developments of imaged capillary isoelectric focusing technology for in-depth biopharmaceutical characterization DOI Creative Commons
Bo Tao, Feng Yang, Bo Yan

et al.

TrAC Trends in Analytical Chemistry, Journal Year: 2025, Volume and Issue: unknown, P. 118212 - 118212

Published: Feb. 1, 2025

Language: Английский

Citations

0
Advancing protein heterogeneity analysis: nano-flow pressure mobilization for precise icIEF fractionation and online MS detection DOI

Teresa Kwok,

She Lin Chan,

Niusheng Xu

et al.

Analytical Biochemistry, Journal Year: 2025, Volume and Issue: 701, P. 115825 - 115825

Published: March 2, 2025

Language: Английский

Citations

0
Post-Column Denaturation-Assisted Hydrophobic Interaction Chromatography−Mass Spectrometry for Rapid and In-Depth Characterization of Positional Isomers in Cysteine-Based Antibody-Drug Conjugates DOI

Zhengqi Zhang,

Anita P. Liu,

Hongxia Wang

et al.

Journal of Pharmaceutical and Biomedical Analysis, Journal Year: 2024, Volume and Issue: 255, P. 116635 - 116635

Published: Dec. 13, 2024

Language: Английский

Citations

1