New pH Gradient Buffer Solutions from Thermo Fisher Scientific Facilitate MAb Charge Variant Analysis

MAbPac™ SCX-10 Columns for the High-Resolution Separation and Analysis of Monoclonal Antibody VariantsThe Thermo Scientific™ MAbPac™ SCX-10 column line has been expanded to include 3 and 5 μm particle sizes for fast, high-resolution analysis as well as rapid separation (RS) columns for bio-UHPLC separations. These smaller-particle-size columns provide the same high resolution as the 10 μm columns, but with significantly faster analysis time. In addition, salt or pH gradients can be used to provide fast high-resolution, high-throughput analysis of monoclonal antibody (MAb) variant samples. The MAbPac™ SCX-10 columns are strong cation-exchange columns designed specifically for the high-resolution, high-efficiency analysis of MAbs and associated variants. The unique nonporous pellicular resin provides exceptionally high resolving power, permitting the separation of MAb variants that differ by as little as one charged residue. Hydrophobic interactions with the resin are eliminated for very efficient peaks.MAbPac™ SCX-10 Monoclonal Antibody Analysis Column Features: Unequalled high-resolution separations Exceptionally high efficiency Highest resolution of monoclonal antibody variants Unmatched column-to-column and lot-to-lot reproducibility Hydrophobic interactions eliminated Ideal for stability testing Column Details: Chemistry: Sulfonic Particle Size: 3, 5, 10 μm Length: 50, 150, 250 mm ID: 2.0, 4.0, 4.6 mm

MAbPac™ SEC– 1 for Monoclonal Antibody (MAb) Analysis MAbPac™ SEC-1 is a size exclusion chromatography (SEC) column designed for monoclonal antibody (MAb) analysis, including monomers, aggregates, and fragments, under non-denaturing conditions, and in both high- and low-salt mobile phases and volatile eluents.SEC is frequently used because of its simple operating principle and features not found in other separation techniques including separating aggregates that are not easily distinguished by other chromatographic means. MAbs produced from mammalian cell culture may contain significant amounts of dimers and higher-order aggregates. The MAbPac SEC-10 is a high-resolution SEC column that is suitable for use with a wide range of biomolecules, including monoclonal antibodies and their aggregates. MAbPac™ SEC-1 Monoclonal Antibody Analysis Column Features: Proprietary hydrophilic bonded layer results in minimal non-desired interactions between the biomolecules and the stationary phase. Nonmetallic and Biocompatible PEEK™ housing eliminates metal contamination from the column hardware. Stable surface bonding leads to low column bleed and compatibility with MS, ELSD and Corona® CAD detection. Rugged, reproducible column. Superior performance for the analysis of monoclonal antibodies, even at low salt concentrations Column Details: Chemistry: Proprietary diol Particle Size: 5 μm Pore Size: 300 Å Length: 50, 150, 300 mm ID: 4.0 mm

pH Gradient Buffer Solutions - Simple method development for charge variant characterization Traditionally cation-exchange chromatography using salt gradients has been successfully used to characterize MAb charge variants. However, additional effort is often required to tailor the salt gradient method for individual charge variants. Thermo Scientific™ pH buffer solutions and kits can be used to generate highly reproducible, linear pH gradients using cation-exchange chromatography.This generic, LC-based platform approach saves time in method development and facilitates method transfer to QA/QC for a wide range of MAb charge variants. Unlike traditional salt gradients, it is possible to predict the pI and the expected retention of the charge variants and use a narrow pH range to get a higher resolution separation.pH Gradient Buffer Solutions Features: Proprietary buffer formulations enable fast,robust and reproducible pH gradients that are simple to optimize and easily automated Ready to usewith existing LC columns and systems, without the need for time-consuming mobile phase adjustments Applicable to the majority of MAbs