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Manufacturing

Biomanufacturing

Projects/Programs

Keyword

Organizational Unit

NISTCHO

Ongoing

An open-access, living reference material for biomanufacturing innovation and collaboration

Optical Coherence Tomography for Label-Free Measurement of Cell Viability in Hydrogel Scaffolds

Ongoing

In the field of tissue engineering, 3D scaffolds and cells are often combined to yield constructs that are used as therapeutics to repair or restore tissue

Optical/electrical particle measurement system

Ongoing

The sizing and counting of subvisible particles in the size range 2 μm to 100 μm is an essential component of product quality assurance in therapeutic protein

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

Pathogen Detection and Identification in the Clinical Setting: The Next Generation of Analyses

Ongoing

NIST and FDA are co-developing DNA-based materials for mixed microbial detection. Our annual workshop brings together private and public interests to discuss

Photonic Dosimetry

Ongoing

As part of the NIST on a Chip program, the Photonic Dosimetry project is developing in-situ sub-micrometer ionizing-radiation dosimetry and calorimetry leading

Point-of-Care Pharmaceutical Manufacturing & Precision Medicine

Ongoing

The COVID-19 pandemic highlighted the need for an agile and resilient pharmaceutical manufacturing and distribution framework. Advancements in manufacturing

Polyelectrolyte Solutions and Gels

Ongoing

We engage with leaders in the pharmaceutical, dental, and personal care research sectors that rely on water soluble polymers (polyelectrolytes) to develop new

Materials Extrusion Additive Manufacturing

Polymer Additive Manufacturing and Rheology

Ongoing

The manufacture of polymeric materials from their raw form into their final useful product occurs under highly non-equilibrium conditions where temperature and

Protein rheology measurements

Ongoing

Therapeutic protein solutions are highly concentrated during manufacturing purification processes and in finished dosage. At such concentrations, the fluid

Prototype Cell Assay Measurement Platform (P-CAMP)

Ongoing

A major focus at NIST is to apply measurement assurance tools to improve the performance of any cell-based assay to achieve a high-end, high-quality documentary

Quantitative, Traceable Determination of Cell Viability Using Absorbance Microscopy

Ongoing

Most cell-based protocols require knowledge of the number of live and dead cell populations. The current methods, however, lack traceability, which is

RMAT Laboratory Programs

Ongoing

The NIST Regenerative Medicine and Advanced Therapies (RMAT) laboratory programs are focused on developing innovative measurement assurance solutions and

Serology and Neutralization Assays for COVID-19

Ongoing

The global response to COVID-19 is leading to rapid advances in diagnostic, surveillance, and vaccine and therapeutic development. A critical measurement

Storage Stability of Freeze-Dried Proteins

Ongoing

We are resolving critical measurement issues that prevent researchers from reliably predicting the chemical and physical storage stability of biomacromolecules

Surrogate protein particle standards

Ongoing

Protein-based drugs can degrade by aggregation into micrometer-sized particles. Such particles, although only a minute fraction of the total protein, sometimes

Synthetic Biology

Ongoing

Synthetic biology is an essential tool for engineering biology.

U.S. TAG for ISO/TC276: Biotechnology

Ongoing

The primary goal of the US Technical Advisory Group (US TAG) to International Organization for Standardization (ISO) Technical Committee (TC) 276 Biotechnology

Thermodynamic Principles Describe and Predict Cell Populations

Ongoing

Characterizing and predicting cell population behavior is critical to the efficiency and flexibility of manufacturing processes of cell-based products

Thermodynamics of Enzyme-catalyzed Reactions

Ongoing

To develop the thermodynamic data and methodology required for effective bioprocess engineering.

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

Validating A.I. Pipelines for Analysis of Live Cell Image Data

Ongoing

Imaging of living cells over time provides unparalleled data of the dynamic cellular characteristics that give rise to complex biological functions

WG1 Terminology

Ongoing

Working Group 1 will work on identification of currently used national and international standards, guidelines and other relevant documents, as well as terms

WG3 Analytical Methods

Ongoing

The ISO/TC 276/WG 3 Analytical methods aims to develop standards for accurate, reproducible and robust measurement and analysis in support of biotechnology. WG

WG4 Bioprocessing

Ongoing

Within bioprocessing, Working Group 4 has currently identified standardization needs in four major technology spaces: 1) component materials control; 2)

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----Biomarker and Genomic Sciences Group
----Cellular Engineering Group
----Biomaterials Group
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----Complex Microbial Systems Group
----Cell Systems Science Group
----Biosystems and Biomaterials Division - HQ
---Chemical Sciences Division
----Biochemical and Exposure Science Group
----Chemical Informatics Group
----Optical Measurements Group
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----Gas Sensing Metrology Group
----Inorganic Chemical Metrology Group
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----Chemical Sciences Division - HQ
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---Biomolecular Measurement Division
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----Bioprocess Measurements Group
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----Biomolecular Measurement Division - HQ
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----Sources and Detectors Group
---Quantum Measurement Division
----Quantum Optics Group
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---Quantum Sensors Division
----Device Fabrication Group
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----Microfabrication Group
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---Nanoscale Device Characterization Division
----Atom Scale Device Group
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-Innovation & Industry Services
--Office of Advanced Manufacturing
---Microelectronics Manufacturing Division
----Microelectronics Manufacturing – HQ
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---Office of Advanced Manufacturing
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---Extension Services Division
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--Director's Office
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----Program Coordination Office - HQ
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----Director's Office - HQ
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----Human Subjects Protection Office - HQ
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----Management and Organization Office- HQ
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