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 package contains all of the original time-domain data as measured by the collaborating partners, converted to NMRPipe format. It also includes corresponding spectra as processed at NIST, and the software scripts and processing parameters that were used to generate the spectra. The entire package is greater than 4 GB. The software NMRPipe, version 9.6 or later, is required for this data package.
About this Dataset
| Title | NMR Interlaboratory Study of NISTmAb |
|---|---|
| Description | 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 package contains all of the original time-domain data as measured by the collaborating partners, converted to NMRPipe format. It also includes corresponding spectra as processed at NIST, and the software scripts and processing parameters that were used to generate the spectra. The entire package is greater than 4 GB. The software NMRPipe, version 9.6 or later, is required for this data package. |
| Modified | 2022-07-20 00:00:00 |
| Publisher Name | National Institute of Standards and Technology |
| Contact | mailto:[email protected] |
| Keywords | NMR , biopharmaceuticals , structure , fingerprint , comparability , biosimilarity , NISTmAb , RM 8671 , Biosciences and Health , interlaboratory study , harmonization , chemometrics |
{
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"references": [
"https:\/\/doi.org\/10.1080\/19420862.2018.1544454",
"https:\/\/dx.doi.org\/10.1021\/acs.jcim.0c00081",
"https:\/\/doi.org\/10.1016\/j.chemolab.2020.103973"
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"fn": "Robert Brinson III"
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"description": "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 package contains all of the original time-domain data as measured by the collaborating partners, converted to NMRPipe format. It also includes corresponding spectra as processed at NIST, and the software scripts and processing parameters that were used to generate the spectra. The entire package is greater than 4 GB. The software NMRPipe, version 9.6 or later, is required for this data package.",
"language": [
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"title": "NMR Interlaboratory Study of NISTmAb",
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"theme": [
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"issued": "2022-08-25",
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