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App Notes

App Notes

Secondary Structure Analysis of NIST Monoclonal Antibody Reference Material 8671 by Microfluidic Modulation Spectroscopy

October 1, 2020

APPLICATION NOTE

This Application Note Includes:

  • NIST mAb RM 8671 is evaluated by MMS, which proves to be a uniquely valuable method for the measurement of higher order structure (HOS) across a wide concentration range
  • MMS yields high quality, reproducible spectra over the measured concentration range.  
  • MMS achieves higher sensitivity across a wider concentration range compared
    to current FTIR techniques

Characterizing Monoclonal Antibody Structure In 2016 the National Institute of Standards and Technology (NIST) made NISTmAb Reference Material (RM) 8671 commercially available for the evaluation of methods used to characterize the structure of monoclonal antibodies. This then serves as a performance control against which novel processes and emerging characterization technologies could be compared. Because this mAb is so widely characterized, its evaluation using Microfluidic Modulation Spectroscopy (MMS) is an important measurement and the first step in characterizing mAbs against a reputable standard.

Using NIST mAb as a test case, MMS is  proven to be a reliable, robust method for measuring higher order structure across a wide concentration range.

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