Nexera XS inert

The potential adsorption of an analyte onto wetted surfaces of UHPLC instruments poses some critical challenges when analyzing biomolecules. While elevated pressure tolerance is required to achieve optimal chromatographic separation through the use columns with a small particle size, the inertness of the wetted surfaces is also of the utmost importance as is resistance to corrosion due to the use of mobile phases with high salt concentrations and extreme pH values. The Nexera XS inert system offers the ideal solution for the separation of molecules by combining the elevated pressure tolerance of a UHPLC system with complete inertness of the sample flow path, ensured by the absence of wetted metal surfaces and offering ultra-high resistance to corrosion.

Modern biotherapeutics, such as monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and nucleic acid drugs provide new modalities to tackle persistent health concerns. To ensure patient safety and therapeutic quality, ICH-Q6B requires biological products to be tested for impurities and or separated during manufacturing process to determine the level of impurities present. Most of these analyses are performed using ultra-high performance liquid chromatography (UHPLC). Using small particles, acid, buffer solutions, organic solvents, and high salt concentrations in standard UHPLC systems can lead to corrosion, accelerated wear, and diminished performance. Analyzing biomolecules by UHPLC also poses some significant challenges due to the potential adsorption of analytes onto the wetted surfaces of the instrument, especially stainless steel materials like needles, tubing, and flow cells. The Nexera XS inert system offers a perfect solution for biopharmaceutical analytical method development, method scouting and quality control by incorporating the high-pressure tolerance of UHPLC alongside complete inertness of the sample flow path, which is achieved by eliminating wetted metal surfaces and offering an ultra-high corrosion resistance for SEC, IEX, and HIC chromatographic methods.