Biologics and Biosimilars Characterization

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facet applications:Biologics and Biosimilars Characterization

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Development of a Simple and Rapid Digestion Protocol for Proteomics Sample Preparation

In this study, we developed a rapid trypsin digest kit that, at elevated temperatures, yielded reliable, reproducible results in less than 2 hours on a wide variety of substrates for mass spectrometry.

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.

Three Methods for Critical Quality Attribute Determination of Monoclonal Antibodies

Step-by-step workflows for the intact mass analysis, peptide mapping, and N-glycan analysis of the monoclonal antibody― adalimumab, for an accurate characterization of the critical quality attributes (CQAs) to ensure drug safety and efficacy. Read more.

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.

Middle-Up Analysis of Antibodies by Reversed-Phase Chromatography

Comparative analysis of different columns in resolving medium-sized fragments of monoclonal antibodies, after digestion using dithiothreitol (DTT) or IdeS (a protease), by Reversed-Phase Chromatography.

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.

Teriparatide Peptide Mapping Analysis by Liquid Chromatography-UV-Mass Spectrometry

This application note describes a step-by-step LC-UV-MS workflow for teriparatide peptide mapping, that includes enzymatic digestion, separation conditions, and their high resolution QTOF mass spectrometer based identification.

Analysis of Activated Nucleotide Sugars by LC-MS/MS

A sensitive LC-MS/MS quantitative method for the simultaneous analysis of highly polar 11 nucleotide activated sugars having similar structures and physicochemical properties using Supel™ Carbon LC column.

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.

A Rapid, Streamlined Workflow for Glycan Sample Preparation and Analysis by LC-MS

The use of PNGase Fast denaturing buffer and enzyme yielded results similar to a conventional 20-hour protocol with overnight digest while reducing workflow time to about 1 hour with a 15-minute digest.

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

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.

Absolute Quantification of Serum Proteome

Absolute Quantification (Protein-AQUA™™) is a targeted quantitative proteomics technique that exhibits robust efficacy and is being increasingly utilized for a wide variety of quantitative proteomics studies.

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.

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.

Enzymes for Antibody Characterization

Antibodies now make up the fastest growing category of therapeutic drugs

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.

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.

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.

O Linked Glycans

O-Linked glycans are usually attached to the peptide chain through serine or threonine residues. O-Linked glycosylation is a true post-translational event and does not require a consensus sequence. The most common type of O-linked glycans contain an initial GalNAc residue

Strategies for Deglycosylating N-Linked Glycans

Explore various strategies for deglycosylating N-linked glycans involving PNGase F, PNGase A (Glycopeptidase A), and even native and sequential deglycosylation with endoglycosidases like Endoglycosidase H, Endoglycosidase F, and exoglycosidases.

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.