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Intact mass analysis is becoming increasingly useful for characterizing biologics. We describe the current application of intact mass analysis, including quantitation, sequencing, and structural characterization.

Intact Mass Analysis of Biopharmaceuticals as its Own Unique Application

Recent developments in high-resolution mass spectrometry (HRMS) are aiding biopharmaceutical development and simplifying routine monitoring, with applications in areas like multi-attribute methods, coupling established purity methods with MS, and subunit analysis.

New Aspects in the Integration of Mass Spectrometry Technologies in the Biopharmaceutical Industry

This article discusses the development of a series of applications that will allow for the determination of a number of nitrosamines that have been identified by the FDA as genotoxins to monitor, initially showing how to perform a separation of these compounds from the API and then looking at how MS can be applied to the analysis to ensure that the required detection limits can be reached. 

Low-Level Determination of Mutagenic Nitrosamine Impurities in Drug Substances by LC–MS/MS

Fanny Caputo is a research scientist at SINTEF (Norway). Her main interests lie in the physical-chemical assessment of nanomaterials, nanoplastic, medical devices, and pharmaceutical products containing nanomaterials, including lipid-based nanoparticles for nucleic acid delivery.

Christian Sieg works as an application scientist for Wyatt Technology and is responsible for instructing customers to utilize Wyatt’s instrumentation. His work includes visiting customers onsite, establishing applications, and training.

A validated FFF-MALS method aligned with technical specification ISO/TS 21362 for the analysis of lipid-based nanoparticles (LNPs) encapsulating siRNA and mRNA is presented.

Meeting Regulatory Needs in the Characterization of Lipid Nanoparticles for RNA Delivery via FFF-MALS

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

Biopharmaceuticals and Protein Analysis | Topics