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Biomanufacturing

Overview

The National Institute of Standards and Technology (NIST) develops measurement science, standards, data, and other tools to accelerate development and manufacture of biopharmaceutical products.

The NIST Biomanufacturing Program draws from a broad array of unique, interdisciplinary expertise, resources, and facilities including

  • biophysical characterization of biotherapeutics including colloidal and rheological measurements
  • state-of-the-art mass spectrometry, NMR, and cryo-electron microscopy capabilities for characterizing biotherapeutics
  • world-class neutron and X-ray scattering facilities to determine biotherapeutic stability and structure

We work closely with stakeholders from across the biopharmaceutical community including industry, FDA, universities, and equipment vendors to identify key measurement problems. NIST holds an annual Biopharmaceutical Measurement Roundtable consisting of members of the industry for feedback on the relevance of its research activities, and to learn of current and emerging measurement needs.

NIST is a trusted, impartial third party that promotes cross-industry collaboration and open data sharing.

Program Portfolio

Foundational measurement science on protein structure, cell biology, and emerging measurement technologies (scattering methods, NMR, HDX-MS, cryo-EM, optical methods) described in over 100 publications.

NIST Engagement with indstury through

Measurement standards and data:

RM 8671 - NISTmAb, Humanized IgG1κ Monoclonal AntibodySRM 8634 - Ethylene Tetrafluoroethylene for Particle Size Distribution and Morphology,  glycan reference materials and data, cell culture for protein reference material development, and mass spectrometry reference data.

News and Updates

The Ins and Outs of a NIST Patent

Electron or X-Ray Beam Lithography in Liquids Description These days, the fabrication of 2D and 3D structures out of liquid, biocompatible, hydrogel solutions

Projects and Programs

U.S. TAG for ISO/TC276: Biotechnology

The primary goal of the US Technical Advisory Group (US TAG) to International Organization for Standardization (ISO) Technical Committee (TC) 276 Biotechnology

WG3 Analytical Methods

The ISO/TC 276/WG 3 Analytical methods aims to develop standards for accurate, reproducible and robust measurement and analysis in support of biotechnology.WG 3

Publications

Cyberbiosecurity for biopharmaceutical products

Author(s)
Elizabeth A. Strychalski, Jennifer Mantla, Jayan Rammohan, Eugenia F. Romantseva, Reid D'Amico, Joel Welch, Leah R. Kauffman, James J. McCarthy, John Schiel, Jeffrey Baker, Kelley Rogers, Kelvin Lee

Conformational gating, dynamics and allostery in human monoacylglycerol lipase

Author(s)
Sergiy Tyukhtenko, Girija Rajarshi, Ioannis L. Karageorgos, Nikolai Zvonok, Kiran Vemuri, Jeffrey W. Hudgens, Xiaoyu Ma, Mahmoud L. Nasr, Alexandros Makriyannis, Kyle W. Anderson, Jason J. Guo, Gerhard Wagner
Inhibition of human Monoacylglycerol Lipase (hMGL) offers a novel approach for treating neurological diseases. The design of inhibitors, targeting active

Awards