μPAC™ LC, a new era in column-to-column reproducibility
contributed by Pharma Fluidics |
Introduction
The importance of establishing robust and reliable analytical methods is of paramount importance in today’s life science research and the (bio)pharmaceutical industry. To meet the required quality specifications imposed by authorities, analytical methods that have proven to yield consistent results are essential. Time and resource consuming processes where these methods need to be re-evaluated and validated, should be avoided at all cost [1]. Liquid chromatography, either coupled with UV detection or mass spectrometry has a prominent position within biomarker discovery and quality control workflows. Among other factors, the quality of the LC column has a significant impact on the data reproducibility and method robustness. LC columns are typically fabricated by packing spherical silica particles into a cylindrical column. Even though column technology has improved enormously in the past decades, batch-to-batch repeatability is still a critical issue that can have a serious impact on LC workflow robustness. Aside batch-to-batch variations (particle size distribution and chemical composition) of the silica material, the packing process itself introduces a certain degree of heterogeneity, preventing the fabrication of multiple LC columns with an identical stationary phase backbone morphology.
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