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Biomanufacturing

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 (biopharmaceutical industry, FDA, 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.

  • The NIST monoclonal antibody reference material (NISTmAb) was characterized by a NIST-led effort involving 100 scientists from industry, government, and academia. The results are documented in a three-volume book, State-of-the-Art and Emerging Technologies for Monoclonal Antibody Characterization.
  • NIST has conducted interlaboratory measurement comparisons with participation from across the industry to benchmark new emerging technologies including NMR, multi-attribute method, and particle measurement systems.

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.

Engagement with industry through

  • consortia (examples: National Institute for Innovation in Biopharmaceutical Manufacturing, Advanced Mammalian Biomanufacturing Innovation Center) and other industry organizations
  • direct collaborations with industry scientists on NMR and mass spectrometry interlaboratory measurement comparisons
  • cooperative research and development agreements with leading biopharmaceutical companies

Measurement standards and data: NIST monoclonal antibody and protein particle reference materials, glycan reference materials and data, cell culture for protein reference material development, and mass spectrometry reference data.

News and Updates

Projects and Programs

HDX-MS for Biopharmaceutical Analysis

This project applies hydrogen/deuterium exchange mass spectrometry (HDX-MS) for determining the dynamical structure of therapeutic antibodies, glycoproteins

WG1 Terminology

Working Group 1 will work on identification of currently used national and international standards, guidelines and other relevant documents, as well as terms

Publications

Interlaboratory Comparison of Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS) MMeasurements of the Fab fragment of NISTmAb

Author(s)
Jeffrey W. Hudgens, Ioannis L. Karageorgos, Elyssia S. Gallagher, Kyle W. Anderson, James J. Filliben, Richard Y. Huang, Guodong Chen, Michael J. Chalmers, Benjamin T. Walters, Jennifer Zhang, John Venable, Caitlin Steckler, In Hee Park, Ansgar Brock, Xiaojun Lu, Ratnesh Pandey, Arun Chandramohan, Ganesh Srinivasan Anand, Sasidhar N. Nirudodhi, Justin Sperry, Jason C. Rouse, James A. Carroll, Kasper D. Rand, Ulrike Leurs, David D. Weis, Mohammed A. Al-Naqshabandi, Tyler S. Hageman, Patrick Wintrode, John D. Lambris, Sarah Urata, George M. Bou-Assaf, Alfonso Espada
Hydrogen-deuterium exchange mass spectrometry (HDX-MS) is an established, powerful tool for investigating protein-ligand interactions, protein folding, and

3D Printing in Cell Culture Systems and Medical Applications

Author(s)
Max J. Lerman, Josephine Lembong, John G. Gillen, John P. Fisher
3D printing serves an important role in various biomedical research applications, including but not limited to culture systems and implantable devices. In this