Pharmaceutical Analysis Blog

Advanced Methods for Biomolecule Analysis

Separation Science, in collaboration with Agilent, offers an eBook covering advanced methods for the analysis of biomolecules, including monoclonal antibodies and biotherapeutics. Glycan and glycosylation analysis, charge variant analysis and monitoring product quality attributes are all covered in the applications highlighted below...

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Sensitive Native Mass Spectrometry of Macromolecules Using Standard Flow LC/MS
Describes a robust and sensitive LC/MS method using standard LC flow for the analysis of native protein analysis. The workflow comprised the Agilent 1290 Infinity II LC, the AdvanceBio SEC column, the 6545XT AdvanceBio LC/Q-TOF, and MassHunter BioConfirm software. READ MORE >>

High-Resolution, High-Throughput Size Exclusion Chromatography Analysis of Monoclonal Antibodies
Demonstrates the use of the Agilent AdvanceBio SEC 200 Å 1.9 μm column for high-resolution and high-throughput size exclusion chromatography (SEC) analysis of a monoclonal antibody (mAb). READ MORE >>

High Resolution Size Exclusion Chromatography Analysis of Small Therapeutic Proteins
Analysis of recombinant human growth hormone (hGH), granulocyte colony-stimulating factor (hG-CSF), and interferon α-2b (INF α-2b) proteins demonstrate the superior performance of the AdvanceBio column for small protein therapeutic applications.

Analysis of Camelid Single-Domain Antibodies Using Agilent AdvanceBio SEC 120 Å 1.9 μm and AdvanceBio HIC Columns
Describes the use of size exclusion chromatography and hydrophobic interaction chromatography for the analysis of camelid single-domain antibodies (nanobodies). Nanobodies are a growing class of single‑domain antibody fragments used for therapeutic purposes.

Monitoring Product Quality Attributes of Biotherapeutics at the Peptide Level Using the Agilent InfinityLab LC/MSD XT System
This study serves as a proof of concept for monitoring multiple product quality attributes (PQAs) using an SQ LC/MS system with software that is recommended for laboratories requiring regulatory compliance.

Critical Quality Attribute Monitoring of mAbs at the Intact and Subunit Levels Using Cost-Effective, Simple and Robust LC/MS
Describes use of the Agilent LC/MSD XT mass selective detector, a single quadrupole LC/MS system with a mass range of 10 to 3,000 m/z, for mass determination of mAbs at intact and subunit levels.

Charge Variant and Aggregation Analysis of Innovator and Biosimilars of Rituximab
This study compares two rituximab biosimilars from different manufacturers to the innovator for their aggregation and charge variant profiles by following two analytical workflows using Agilent 1260 Infinity II bio-inert LC and Agilent AdvancedBio columns.

Streamlined Workflows for N-Glycan Analysis of Biotherapeutics Using Agilent AdvanceBio Gly-X InstantPC and 2-AB Express Sample Preparation with LC/FLD/MS
Describes the preparation and analysis of released N-glycans from biotherapeutic glycoproteins using two labels, InstantPC and 2-aminobenzamide (2-AB).

A Comprehensive Approach for Monoclonal Antibody N-linked Glycan Analysis from Sample Preparation to Data Analysis
This study demonstrates how to increase sample throughput for glycan characterization workflows using the Agilent AssayMAP Bravo liquid handling platform.

Profiling Glycosylation of Monoclonal Antibodies at Three Levels Using the Agilent 6545XT AdvanceBio LC/Q‑TOF
A complete workflow solution for antibody glycoforms characterization by integrating the Agilent AssayMAP Bravo liquid handling platform, UHPLC technologies, the Agilent 6545XT AdvanceBio LC/Q-TOF, and Agilent MassHunter BioConfirm software.

Glycopeptide Characterization for Various Monoclonal Antibodies Using the Agilent 6545XT AdvanceBio LC/Q-TOF
An optimized LC/MS workflow for mAb glycopeptide characterization using the Agilent AssayMAP Bravo liquid-handling robot, the 1290 Infinity II LC system, the 6545XT AdvanceBio LC/Q-TOF, and automatic data analysis using MassHunter BioConfirm software.

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