Special Issues-11-01-2019

Click the title above to open the Advances inBiopharmaceutical Analysis 2019 special issue in an interactive PDF format.

Given the complexity of producing bispecific antibodies, suitable analytical methods to detect and measure the levels of undesired variants are essential. Here, a novel MS-based method for variant detection is presented.

An introduction to this special issue by our guest editor

Long-term column use can lead to on-column methionine oxidation during LC–MS/MS peptide mapping of antibody-based biotherapeutics. Following the approach described here minimizes the risk of measuring oxidative artifacts, and helps generate high quality data to provide reliable quantitative information about product-related heterogeneities.

Applications of size-exclusion chromatography (SEC) are presented for characterization and quality control of novel biotherapeutic products, including antibody–drug conjugates, hydrophobic proteins, and coformulations.

In this study, a conjugation strategy for Fab–ferritin conjugates, used for drug delivery, was successfully optimized using LC–MS. Characterization of the resulting conjugates was performed using SEC-MALS-QELS.

The potential of multidimensional online peptide mapping analysis as a strategy for improving a postlabeling workflow for protein–protein interactions is demonstrated using both hydroxy radical footprinting–mass spectrometry (HRF–MS) and LC–MS/MS.

A simple and robust size-exclusion chromatography (SEC) method has been developed for characterizing a multimeric PEG–protein conjugate. A wide range of size variants of the conjugate, ranging from 50 kDa to >1000 kDa, can be resolved and quantitated.