Domain characterization of therapeutic antibody products in regulated environments

Due to the artifact free sample preparation, ease of use and simple data interpretation FabRICATOR (IdeS) has become a valuable tool for routine characterization of mAb based bioteheraputics.

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FabRICATOR was described in a recent paper by Merck Research Laboratories (1) for domain characterization of therapeutic antibody products. IgG1, IgG2, IgG4 and Fc-fusion proteins were investigated using FabRICATOR domain analytics. Each molecule’s unique chromatographic profile supports a simple strategy for an identity test, an important formal quality control measure in the biopharmaceutical industry (figure 1). The authors conclude that the FabRICATOR workflow is a platform approach for convenient analytics suitable for regulated environments, stability testing and batch release assays.

rp-hplc-ides-digested-Igg1-Igg2-Igg4-fc-fusionprotein

Figure 1. RP HPLC of IdeS digested IgG1 (A1-A5), IgG2 (B1-B3), IgG4 (C1-C2), and Fc fusion protein (F1) molecules.

Advantages of domain characterization over peptide mapping:

  • Rapid and easy sample preparation
  • Ease of data interpretation
  • Fewer method artifacts
  • Site correlation

1. An Y, Zhang Y, Mueller HM, Shameem M, Chen X. A new tool for monoclonal antibody analysis: Application of IdeS proteolysis in IgG domain-specific characterization. mAbs 2014; 6:39 - 38; http://dx.doi.org/10.4161/mabs.28762

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