Recent Developments in Biopharmaceutical Analysis

The articles presented here highlight important recent developments in biopharmaceutical analysis.

Multi-isocratic elution mode is a powerful chromatographic approach for characterizing minor isoforms of monoclonal antibodies.

Flow-through immobilized-enzyme reactors (IMERs) can streamline protein digestion for bottom- and middle-up LC–MS characterization while providing high accuracy and reproducibility.

Commercially available trypsin IMERs can digest proteins with high sequence coverage and robustness, facilitating online multidimensional LC–MS.

Leading biopharmaceutical companies are integrating HPLC into production processes for monitoring critical quality attributes (CQAs) with high-resolution mass spectrometry (HRMS) detection.

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This work compares at-line Protein A-MS with a standard multi-attribute method (MAM) workflow for analyzing product quality attributes (PQAs) during upstream processing.

High-resolution mass spectrometry (HRMS) is an increasingly critical tool for identifying, characterizing, and monitoring attributes of protein-based therapeutics.

If we are going to achieve widespread adoption of multidimensional separations, we need more systematic approaches to method development that rely less on user experience.