Rugged HPLC Column Supports Biotherapeutic Drug Development

New HPLC column designed for exceptional resolution in antibody characterization and separation

22 Jun 2015
Lois Manton-O'Byrne, PhD
Executive Editor

A new high-performance liquid chromatography (HPLC) column designed for reversed-phased chromatography separation of monoclonal antibodies (mAbs) and their fragments.

The Thermo Scientific MAbPac RP column is designed for analytical chemists requiring high-resolution accurate mass determination of mAb variants, antibody drug conjugates (ADCs) and proteins, as well as those conducting high-resolution separation of mAbs and mAb fragments (including LC, HC, Fc, Fab, scFc, and F(ab’)2).

With mAbs already representing more than a third of all biopharmaceuticals in development, reliable and rapid characterization of these compounds is becoming increasingly vital for many labs. The MAbPac RP column has been optimized for mAb LC/MS and LC/UV separations: its thermal and pH stability yields consistent separations, while the polymeric resin has a pore size that is optimal for mAbs.

“These columns provide outstanding resolution for monoclonal antibodies and related biomolecules,” said Dr. Xiaodong Liu, director of chromatography consumable R&D for Thermo Fisher. “In addition to being rugged, they offer users in biopharma R&D and academia high efficiency with a low carry-over, coupled with excellent compatibility with mass spectrometry and high throughput capabilities.”

The MAbPac RP column will be exhibited for the first time at the 42nd International HPLC Conference in Geneva, Switzerland, Booth 14, June 21–25.

This column has been developed specifically with the biomolecules being separated in mind: the polymer, pore size and surface chemistry have all been optimized to give results that are highly accurate and reproducible. The new MAbPac column complements the existing Thermo Scientific MAbPac family of columns, including the MAbPac SEC-1, MAbPac HIC family of columns, MAbPac SCX-10, and MAbPac Protein A, as well as the BioRS UltiMate 3000 system.

Thermo Scientific™ MAbPac™ HIC-10 Monoclonal Antibody Column

Thermo Fisher Scientific

Designed for separation of monoclonal antibodies (MAbs) and related biologics by hydrophobic interaction, the Thermo Scientific™ MAbPac™ HIC-10 LC column is a high resolution silica column. The MabPac HIC-10 column's unique chemistry provides high resolution, excellent biocompatibility, and selectivity that is different from other HIC columns on the market. The MAbPac HIC-10 column is based on high-purity, spherical, wide-pore (1,000Å), 5μm silica particles functionalized with proprietary alkyl amide groups. Its advanced surface bonding technology leads to excellent chemical stability, high efficiency, and unique selectivity optimized for MAbs and different from other HIC phases.Features: Excellent biocompatibility and extremely low carryover High resolution and high efficiency Compatible with both organic solvent and aqueous mobile phases Rugged column stability Column Details: Type: Hydrophobic Interaction, Alkyl amide Particle Size: 5 µm Pore Size: 1000 Å Length: 100, 250 mm ID: 4.6 mm

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Thermo Scientific™ MAbPac™ SCX-10 Monoclonal Antibody Analysis Column

Thermo Fisher Scientific

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

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Thermo Scientific™ MAbPac™ SEC-1 Monoclonal Antibody Analysis Column

Thermo Fisher Scientific

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

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