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.
This is the first article in a four-part series exploring the quantitative assessment of drugs and their metabolites in biological fluids (such as blood, plasma, and urine) and tissue homogenates using liquid chromatography–mass spectrometry (LC–MS).
Solid adsorbent gas chromatography (GC) columns, such as porous layer open tubular (PLOT) columns, are the best option for GC analysis of C1–C5 hydrocarbons, but water can affect retention and selectivity. We review the effects of water for different types of PLOT columns, and explain how to prevent or remediate the problem.
In recent articles, we reviewed the basic concepts of extracolumn dispersion and how this phenomenon can impact the quality of an LC separation. We now specifically discuss the effects of dispersion that can occur due to tubing