New Breakthrough in Biologics Analysis with Bioinert, Biocompatible and High-Pressure UHPLC

Overview

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.