NMR Interlaboratory Study of NISTmAb

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.