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Biomanufacturing

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 industry 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

Projects and Programs

Assay Development for Cell-Free Expression Systems

Ongoing
Current practices for characterizing cell-free expression systems are limited and unsuitable to advance these technologies beyond the state-of-the-art. To meet this measurement need, the Cellular Engineering Group is developing quantitative assays to benchmark cell extracts, reagents, and cell-free

Orthogonal Measurements

Ongoing
Definitions: Orthogonal measurements: Measurements that use different physical principles to measure the same property of the same sample with the goal of minimizing method-specific biases and interferences. Complementary measurements: Measurements that corroborate each other to support the same

LNP-RNA Research Grade Test Material

Ongoing
The currently planned LNP/RNA material (designated RGTM 10240) will include a fragment of the SARS-CoV-2 genome that is approximately 4 kb in length. This fragment was previously included (in unencapsulated form) as “Fragment 1” of NIST RGTM 10169. The RNA fragment is not designed for cell-based

Publications

Mechanism of Action, Potency and Efficacy: Considerations for Cell and Gene Therapies

Author(s)
Carl Simon Jr., Anne L. Plant, Catherine Zander, Erich Bozenhardt, Christina Celluzzi, David Dobnik, Melanie Grant, John Hughes, Uma Lakshmipathy, Kok-Seong Lim, Laura Montgomery, Hesham Nawar, Thiana Nebel, Linda Peltier, James Sherley, Rouzbeh Taghizadeh, Eddie Tan, Sandrine Vessillier
One of the most challenging aspects of cell and gene therapy products (CGTPs) is defining mechanism of action (MOA), potency and efficacy of the product. This

Comparison of N-glycopeptide to released N-glycan abundances and the influence of glycopeptide mass and charge state on N-linked glycosylation of IgG antibodies

Author(s)
Concepcion Remoroza, Meghan Burke Harris, Tytus Mak, Sergey Sheetlin, Yuri Mirokhin, Zachary Goecker, Brian T. Cooper, Mark Lowenthal, Xiaoyu (Sara) Yang, Guanghui Wang, Dmitrii V. Tchekhovskoi, Stephen E. Stein
We report the comparison of mass-spectral-based abundances of tryptic glycopeptides to fluorescence abundances of released labeled glycans and the effects of

Awards