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This concise yet comprehensive overview of sample preparation for bioanalysis looks at sample preparation fundamentals, best practices, and modern trends—all illustrated with a case study.

Bioanalytical Analysis of Small-Molecule Drugs and Metabolites in Physiological Samples by LC–MS, Part 2: Sample Preparation

There is a need to use more descriptive and precise terms to describe some of the properties of the products used for biopharmaceutical analysis. It is probably more correct to say “low adsorption” and “corrosion-resistant” systems.

Defining Material Used in Biopharmaceutical Analysis

We present the main analytical techniques for performing functional characterization of biotherapeutic products. Such assessments are particularly critical for biosimilars, where analytical testing must ensure functional comparability with the innovator product.

Tools for Functional Assessment of Biotherapeutics

We explore the impact of two different stationary phases and ion-pair reagents on the retention behavior of a therapeutic peptide using reversed-phase liquid chromatography. This information is of fundamental importance for the development of reliable, selective, and fast analytical methods able to separate and identify the target peptide.


The Role of Adsorption and pH of the Mobile Phase on the Chromatographic Behavior of a Therapeutic Peptide

Sophia Kenrick, PhD,* is an application scientist at Wyatt Technology Corporation, 6300 Hollister Ave, Santa Barbara, CA 93117-3253.

Quantifying AAV Quality Attributes Using SEC–MALS

The benefits of a robustness assessment for the analysis of a NIST mAb using a wide pore C4 LC column are described.

Method Robustness and Reproducibility for Monoclonal Antibody Purity Analysis

In the second part of this review of the current state of HIC, some practical considerations are explained, including method development, selection of the phase system, combined salt systems, and possibilities to combine HIC with other chromatographic modes.

Hydrophobic Interaction Chromatography (HIC) for the Characterization of Therapeutic Monoclonal Antibodies and Related Products, Part 2: Practical Considerations

A review of the current state of HIC, focusing on retention and separation mechanisms with the aim of developing more robust methods. Can HIC be considered as a non-denaturing and non-destructive technique with advantages for protein analysis?

Hydrophobic Interaction Chromatography (HIC) for the Characterization of Therapeutic Monoclonal Antibodies and Related Products, Part 1: Theoretical Aspects

Recent advances in stationary phases for hydrophobic interaction chromatography (HIC) permit HIC–MS analysis of intact antibodies and other proteins using direct flow to the mass spectrometer.


Online Hydrophobic Interaction Chromatography–Mass Spectrometry (HIC–MS) Analysis of Proteins

New analytical workflows are needed to address the advances in biopharmaceutical product composition. A description of the multi-attribute method (MAM) is given, which has been developed to monitor critical quality attributes (CQAs) simultaneously and directly.


Biopharmaceuticals and Protein Analysis | Topics