Protein characterization and analysis are critical to the development, quality control, and regulatory oversight of biopharmaceuticals, including vaccines, monoclonal antibodies, gene therapies, and biosimilars. Although imaged capillary isoelectric focusing (icIEF) has emerged as the go-to method for separation, quantitation, and identification of charge variants in proteins, the technique suffers a key limitation: the inability to fractionate charge variants for in-depth characterization. Ion-exchange chromatography (IEX), comprising time-consuming liquid handling and sample prep steps, is typically required to collect fractions for subsequent mass spectrometry (MS) analysis. This laborious and time-consuming workflow can take days, weeks, or longer, before the full structural picture can be achieved.
The new MauriceFlex™ from Bio-Techne streamlines the process—and accelerates decision-making—by combining protein charge isoform fractionation with icIEF and CE-SDS analysis in one instrument. Not only does MauriceFlex provide same-day, icIEF-based fractionation, the fractions are of high purity, and a single fractionation run yields enough material for intact MS analysis. Cartridges are compatible with urea and methylcellulose, and fractions can be pooled for peptide mapping. Routine CE-SDS and cIEF assays can be performed on the same instrument, and bridging studies can be eliminated. A micro-preparative fractionation option can further lower the costs of using MauriceFlex. High-resolution, offline fractionation of charge variants also offers the flexibility to apply multiple analytical assays for characterization, depending on your lab’s needs.
For those already using Maurice for icIEF, upgrading is simple; method development, transfer, and re-validation steps are reduced because previous analytical icIEF and CE-SDS methods developed on the Maurice platform can be transferred to the MauriceFlex without modification.
A case study using MauriceFlex for icIEF fractionation of the antibody component of an antibody-drug conjugate (ADC) achieved high purity fractions (80–100%) in a single run and a faster pathway to intact MS analysis of the charge variants. The charge variants collected with the MauriceFlex fractionation cartridge matched the charge variant profile of Maurice icIEF, and fractions allowed scientists to choose their method for characterizing the charge isoforms. Fast and easy fraction collection also allowed for further characterization including peptide mapping, and the results correlated well with those in existing literature.
The groundbreaking MauriceFlex from Bio-Techne accelerates biopharmaceutical development and QC by going beyond routine size and charge analysis and allowing your lab to conduct an in-depth study of your molecule at any stage of development. The result is accelerated decision-making, better outcomes, and lower costs.