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The NISTmAb Interlaboratory NMR Study is a joint effort between 25 organizations to evaluate the performance of two-dimensional (2D) heteronuclear NMR as used to characterize the high order structure (HOS) of proteins, with the aim of harmonizing 2D-NMR methods to support industrial use of NMR as applied to mAb therapeutics. This study features nearly equal representation between laboratories from academia, government, and industry, including 4 laboratories from regulatory agencies.

In the study, each participating lab measured a series of NMR spectra on the NIST-Fab, which was derived by papain cleavage of the NISTmAb. A 20%-enriched ¹³C, uniformly enriched ¹⁵N NIST-Fab, produced from Pichia pastoris, served as the system suitability sample.

 

This summary slide deck describes the collection of 375 ¹H, ¹³C and 75 ¹H, ¹⁵N 2D NMR data produced by the study.