Leveraging NISTmAb Prior Knowledge to Demonstrate Analytical Competency

The NISTmAb IgG1κ monoclonal antibody reference material, from the National Institute of Standards and Technology, is intended for use in evaluating the performance of analytical methods that determine physicochemical attributes of biologics. As a case study, Almac Sciences have assessed NISTmAb and its prior knowledge to demonstrate competency in chromatography and capillary electrophoresis methods.

Key Takeaways:

  • Analytical challenges during establishment of NISTmAb methods.
  • Comparability assessment of NISTmAb data to demonstrate analytical competency.
  • Transition of capillary electrophoresis methods from 32Karat software to Empower software.

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