BioResolve SEC mAb Consumables

SEC Solutions for mAb Aggregate, Monomer, and Fragment/Clip Analyses

A solution purposely designed for organizations involved in the research and/or development of monoclonal antibody (mAb) drugs that require accurate quantitation of mAb aggregates (HMWS), monomers, and fragments/clips (LMWS); providing reliable, high-quality, SEC analytical data which addresses internal and regulatory concerns regarding these biotherapeutics. The BioResolve SEC mAb Columns and Guards provide:

Out-of-the-box performance
Tested with a relevant mAb size variant standard to help ensure consistent column-to-column and batch-to-batch performance, regardless of LC platform used
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Separation of mAb aggregates, monomers, and fragments of NIST mAb RM 8671 and Waters mAb Size Variant Standard

Out-of-the-Box SEC Performance

The BioResolve SEC mAb Columns and Guards are specifically manufactured and quality control tested to deliver reproducible, accurate quantitation of monoclonal antibodies (mAbs), associated high molecular weight aggregates (>300,000 Da), and lower molecular weight fragments (e.g., <100,000 Da). A range of available column sizes provides flexibility for performance optimization on a variety of chromatographic platforms, ranging from higher dispersion HPLC to lower dispersion UPLC systems.

Batch-to-Batch and Column-to-Column Consistency

BioResolve SEC mAb Columns and Guards are manufactured in a cGMP, ISO 9001 certified plant using stringent manufacturing protocols and ultra-pure reagents. Each batch of stationary phase must pass a series of stringent QC tests. Individual packed columns are tested for efficiency and then for mAb performance using the Waters mAb Size Variant Standard to ensure column-to-column consistency for this challenging application. The results for the mAb Size Variant Standard separation and uracil efficiency for each individual column is included in the column box.

Separation of Waters mAb Size Variant Standard on four different BioResolve SEC Columns

Reliably separate and quantiate mAb monomer species from fragments

LC System Agnostic

LC system dispersion can have a significant effect on the ability of a selected SEC column to reliably separate and quantitate mAb monomer (@ 150 kDa) species from lower molecular fragments/clips (i.e., <100 kDa). To address this concern, BioResolve SEC mAb Columns are available in a variety of dimensions to provide flexibility for performance optimization on a variety of chromatographic platforms, ranging from higher dispersion HPLC to lower dispersion UPLC systems.

NIST-based mAb Size Variant Standard

The Waters mAb Size Variant Standard is comprised of a NISTmAb (NIST Reference Material [RM] 8671, a humanized monoclonal antibody) and non-reduced IdeS digested NISTmAb fragments F(ab')₂ (~100,000 Da) and (Fc/2)₂ (~50,000 Da), two mAb fragments with similar molecular weights as the Fab/c and Fab or Fc, respectively. This standard is used for the quality control of all BioResolve SEC mAb Columns as well as to help test LC system, column, and method prior to analysis of valuable samples.

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