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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
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.
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 Antibody, SRM 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.