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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

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

Tissue Engineering Measurands

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

Cell Counting for Cell Therapies

Cell counting (or cell enumeration) is one of the most fundamental measurements in biotechnology, from biomanufacturing to medical diagnosis to advanced therapy

NIST Genome Editing Consortium

The National Institute of Standards and Technology Genome Editing Consortium addresses the measurements and standards needed to increase confidence and lower

Publications

Report of the 2019 NIST-FDA Workshop on Standards for Next Generation Sequencing Detection of Viral Adventitious Agents in Biologics and Biomanufacturing

Author(s)
Megan Cleveland, Bharathi Anekella, Mike Brewer, Pei-Ju Chin, Heather Couch, Eric Delwart, Jim Huggett, Scott Jackson, Javier Martin, Serge Monpoeho, Tom Morrison, Siemon Ng, David Ussery, Arifa Khan
Adventitious virus testing assures product safety by demonstrating the absence of viruses that may have been unintentionally introduced during the manufacturing

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

Awards