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Biomanufacturing

Overview

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

Events

Projects and Programs

Orthogonal Measurements

Ongoing
Reliable measurements of quality attributes of medical products are required for quality control and verification of safety and efficacy. To reduce (i) the risk

Tissue Engineering Measurands

Ongoing
Cell viability is often measured as a quality metric of tissue engineered medical products. However, there are a number of inherent assumptions about cell

Publications

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