Biologics and Biosimilars Characterization

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Showing 1-26 of 26 results

Optimising the LC-MS Analysis of Biomolecules

We present an article concerning optimising the LC-MS analysis of biomolecules.

Robust, load independent viral clearance in monoclonal antibody purification with Natrix® Q chromatography membrane

Membrane adsorbers are a cost-effective, robust, single-use solution for monoclonal antibody polishing

Analysis of Oligonucleotides by SEC-MALS

Separation and identification of oligonucleotides differing by one base in length using Size Exclusion Chromatography combined with multi-angle light scattering (SEC-MALS) detector.

Fast and high-resolution Analysis of Intact Therapeutic Monoclonal Antibody Trastuzumab using BIOshell™ A400 Protein C4 Column

Optimization of a Reversed-Phase Liquid Chromatographic (RP-LC) method for the intact analysis of a therapeutic monoclonal antibody, trastuzumab, using a BIOshell™ A400 Protein C4 column.

A Comparison of Superficially Porous Particle-based Column Chemistries for Peptide Mapping

This application note compares three different column chemistries from the BIOshell™ line of columns with superficially porous particles to evaluate their performance in peptide mapping.

Middle Up Mass Analysis Using Trastuzumab as Model Protein

A RPLC-MS workflow for mass analysis of reduced monoclonal antibody, trastuzumab, including reduction procedures, calibration, and system suitability tests.

A RPLC-MS workflow for mass analysis of non-reduced monoclonal antibody, trastuzumab, including calibration, and system suitability tests.

Strategies for Deglycosylating N-Linked Glycans

Explore strategies for releasing N-linked glycans with PNGase F, PNGase A & native & sequential deglycosylation with endoglycosidases & exoglycosidases.

Absolute Quantification of Serum Proteome

Protein-AQUA™™ offers robust targeted proteomics for quantitative studies across diverse research areas.

Quality Attribute Determination of Monoclonal Antibodies

Workflows for monoclonal antibody adalimumab characterization ensure drug safety and efficacy through critical quality attribute analysis.

Rapid Glycan Prep & Analysis by LC-MS Workflow

PNGase Fast denaturing buffer and enzyme provide results similar to a conventional 20-hour protocol, reducing workflow time to about 1 hour.

Teriparatide Peptide Mapping Analysis by LC-UV-MS

LC-UV-MS workflow details teriparatide peptide mapping, including enzymatic digestion, separation conditions, and QTOF mass spectrometer identification.

Analysis: Activated Nucleotide Sugars by LC-MS/MS

LC-MS/MS method quantifies similar polar nucleotide activated sugars using Supel™ Carbon LC column for simultaneous analysis.

Improving the Chromatographic Separation of DMB-Labeled Sialic Acids for the Comparison of Biosimilars to Reference Materials

A significantly improved HPLC-fluorescence method for DMB-NANA and -NGNA, and application of this method to compare 2 candidate biosimilar therapeutic proteins to their respective RMs.

Rapid Trypsin Digestion of Complex Protein Mixtures for Proteomics Analysis

Reliable and reproducible results in mass spectrometry proteomics analyses are highly dependent on robust sample preparation.

Quantification of Host Cell Proteins

Residual presence of host cell proteins (HCPs) in recombinant therapeutic products has considerable clinical safety risks associated with a potential immunological response in patients.

Workflow for the Analysis of Polysorbate 80 in Erbitux® Formulation

A complete reversed phase HPLC-ELSD workflow, including sample preparation for the analysis of Polysorbate 80 in a monoclonal antibody formulation.

Enzymes for Antibody Characterization

Antibodies now make up the fastest growing category of therapeutic drugs

Released N-Glycan Analysis of a Therapeutic Antibody Using BIOshell™ Glycan Column

This application note describes the released N-Glycan analysis of a monoclonal antibody, cetuximab, labeled with procainamide, using a BIOshell™ Glycan HPLC column.

UHPLC-MS Bottom-Up Analysis of Trastuzumab on a BIOshell™A160 Peptide C18 Column

Learn about UHPLC-MS analysis of trastuzumab on a BIOshell™ 160A peptide C18 column and discover reduced solvent consumption in peptide mapping using 1.5 mm I.D. columns.

Correlation of FcR Affinity Chromatography with Glycan Pattern and ADCC Activity of a Therapeutic Antibody

Fast assessment of antibody-dependent cell-mediated cytotoxicity (ADCC) and glycoform pattern of a therapeutic antibody rituximab by FcγRIIIa affinity chromatography.

Charge Variant Analysis (CVA) with Strong Cation Exchange

Learn about the separation of several charge variants of two monoclonal antibodies, NISTmAb and Infliximab, using a polymeric cation exchange column and MS-compatible mobile phases.

Simple Digestion Protocol for Proteomics Sample Prep

Rapid trypsin digest kit yields reliable results in less than 2 hours for mass spectrometry analysis.

O Linked Glycans

O-Linked glycans attachment to peptides involves various residues, particularly GalNAc, known as mucin-type glycans.

Difluoroacetic Acid as an Effective Mobile Phase Modifier for the LC-UV/MS Analysis of Proteins

The article describes the use of difluoroacetic acid (DFA) as an effective alternative to acid modifiers, formic acid (FA) and trifluoroacetic acid (TFA) in the LC-UV/MS analysis of proteins.

Middle-Up Antibody Analysis by RP Chromatography

Compare columns in resolving medium-sized antibody fragments after digestion with DTT or IdeS using Reversed-Phase Chromatography for analysis.