"Critical to Quality" Measurements of Protein Aggregation in Biopharmaceuticals

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In this article, we review some key considerations for chromatographic technique selection and method development across the full drug process—from early-stage active pharmaceutical ingredient (API) synthesis to routine commercial release activities.

In this column, we discuss the label-free and stable isotope labeling proteomics approaches that help in biomarker discovery. We also discuss the different enrichment techniques, such as stable isotope labeling by amino acid in cell culture (SILAC), isobaric tags for relative and absolute quantitation (iTRAQ), and tandem mass tags (TMT, that help in measuring low-abundance protein biomarkers.

Ronald Piervincenzi, chief executive officer of the United States Pharmacoepia, focused on how collaboration and component quality can improve worldwide pharmaceutical production standards during a lecture at the Eastern Analytical Symposium (EAS) last month.

Organic solvents are generally not compatible with ion chromatography (IC) systems. The approach presented here assists the use of organic solvents for sample preparation and provides a mechanism for the removal of the organic solvents from the chromatographic flow path.

Three analytical and two pre-treatment methods—gas chromatography–mass spectrometry (GC–MS), gas chromatography–tandem mass spectrometry (GC–MS/MS), and liquid chromatography–tandem mass spectrometry (LC–MS/MS) plus liquid-liquid extraction (LLE) and dried blood spot (DBS) —were compared for the quantitation and characterization of barbiturates.