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The National Institute of Standards and Technology (NIST), in collaboration with the American Association of Pharmaceutical Scientists (AAPS), is coordinating
Protein drugs are the top selling pharmaceuticals worldwide, a hundred billion dollar industry, but also the fastest growing category of health care costs. The
Cell counting (or cell enumeration) is one of the most fundamental measurements in biotechnology, from biomanufacturing to medical diagnosis to advanced therapy
Cells derived from different organisms and tissues have been established and are used in bioresearch and for the production of complex biological products. The
A Paradigm Shift in Addressing Antimicrobial Resistance: Measuring the Transition Between Antibiotic Susceptibility and Resistance With the exception of our own
As ‘omics moves into industrial and commercial applications, there is a need for quality and process control to ensure safety and efficacy of products and
According to the National Science and Technology Council (NSTC) report on Strategy for American Leadership in Advanced Manufacturing 1 and recent industrial
An important determinant of cellular response to drugs and toxins is the chemical and physical nature of the extracellular matrix (ECM) to which cells are
In July 2014, ERCC members initiated the ERCC 2.0 effort to develop an updated suite of RNA controls that will keep pace with advances in RNA measurement
The purpose of this project is to create rheological measurement methods and tools, focused on using minimal fluid volumes, to measure local flow dynamics and
This project applies hydrogen/deuterium exchange mass spectrometry (HDX-MS) for determining the dynamical structure of therapeutic antibodies, glycoproteins
Despite their promise to enable high-throughput science and discovery, microfluidic devices have not yet been broadly adopted. An important missing element in
Induced pluripotent stem cell (iPSC) populations are complex, dynamic and heterogeneous. Individual cells within a population are constantly changing, while
The National Institute of Standards and Technology is developing a mass spectral library of all identifiable components derived from the digestion of monoclonal
This project, now concluded, developed novel imaging and image analysis tools to examine individual cells and cell populations within the complex chemical
NOW AVAILABLE The NIST monoclonal antibody (NISTmAb) reference material, RM 8671, is intended for use in evaluating the performance of methods for determining
The "first-of-its-kind" in an entirely new class of reference material, NIST PS1 Primary Standard for quantitative NMR (Benzoic Acid) is now available! The PS
The latest release of the NIST Mass Spectral Library, which includes the NIST Tandem Mass Spectral Library and NIST/EPA/NIH Mass Spectral Library and NIST GC
Reliable measurements of quality attributes of medical products are required for quality control and verification of safety and efficacy. To reduce (i) the risk
The COVID-19 pandemic highlighted the need for an agile and resilient pharmaceutical manufacturing and distribution framework. Advancements in manufacturing
Therapeutic protein solutions are highly concentrated during manufacturing purification processes and in finished dosage. At such concentrations, the fluid
The NIST Regenerative Medicine and Advanced Therapies (RMAT) laboratory programs are focused on developing innovative measurement assurance solutions and
We are resolving critical measurement issues that prevent researchers from reliably predicting the chemical and physical storage stability of biomacromolecules