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Thank you for your continued interest in LCGC's content series on Demonstrated Benefits of Low–flow Analytical Methods for Biopharmaceutical Applications. The Executive Summary is now available.

The growing prevalence of next generation biopharmaceuticals means that drug product characterization is no longer confined to simple small molecule analysis. This necessitates incorporation of analytical methods capable of performing in-depth macromolecule characterization while maintaining requisite levels of sensitivity, precision, and throughput, such as that obtained using liquid chromatography-mass spectrometry (LCMS) methods. While many may associate the low-flow range of ultra-high performance liquid chromatography (UHPLC) with bottom-up proteomics, the true versatility of UHPLC brings many appealing advantages to bioanalysis in conjunction with high-resolution mass analysis. Low-flow systems are effective for intact protein and peptide determination with robust results, and even carry improvements in sensitivity relative to conventional LC separations.

Systems such as the Thermo Scientific™ Vanquish™ Neo UHPLC system are well suited for applications as diverse as monoclonal antibody assessment, host cell protein analysis for initial process screening, and characterization of next generation biotherapeutics, such as Adeno-associated virus (AAV) proteins. Examples of these applications will be discussed herein along with key facets of UHPLC instrumentation.

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