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Health

Cell and gene therapy

Projects/Programs

Displaying 1 - 25 of 25
Optical coherence tomography

Biofabrication of Tissue Engineered Constructs

Ongoing
OCT imaging was assessed using a model scaffold-cell system consisting of a polysaccharide-based hydrogel seeded with human Jurkat cells. Four test systems were used: hydrogel seeded with live cells, hydrogel seeded with heat-shocked or fixed dead cells and hydrogel without any cells. Time series

Bioimaging

Completed
Imaging and image analysis are used ubiquitously in biological and biomedical research. One of the great advantages of imaging is its intuitive information content; much can be learned from just a glance at the data. On the other hand, these data generally contain a very large amount of untapped

Bioprocessing Laboratory

Ongoing
Current Capabilities Computer controlled liquid nitrogen biostorage system Two culture areas including 4 monitored CO2 incubators 2 Six-foot BSLII biosafety cabinets Measurements- cell count and concentration, STR typing, flow cytometry, cell volume size distribution, conventional transmission and
Measurement Assurance Framework

Building Measurement Confidence for Cell Characterization

Ongoing
NIST collaborates with key stakeholders in industry, other government agencies, and academia to develop measurement assurance strategies and advanced measurement capabilities for cell characterization. Data and concepts developed through workshops and laboratory programs inform the development of

Cell Viability for Advanced Therapies

Ongoing
In the Biosystems and Biomaterials Division at NIST, we have established several technical programs to support the development and implementation of cell viability assays in advanced therapies. These programs address key needs in cell viability assay development including selection and development

Gene Delivery Systems

Ongoing
Viral Vectors Viral vectors are a critical tool for delivering DNA or RNA into patient’s cells. Common viral vectors for gene therapy include adenovirus, lentivirus, and adeno associated virus. Administration of viral vectors can occur in vivo or ex vivo , such as for adeno associated virus or
MML researchers develop reference materials and methods for quantitative phase microscopy with off-the-shelf products

Measurement Assurance for Quantitative Cell Imaging by Optical Microscopy

Ongoing
Light microscopy is unparalleled as a quantitative technique for studying cell biology, but assuring that the results of measurements and analyses are accurate, repeatable and sharable is challenging. Here we provide information on reference materials, protocols and approaches for evaluating the

Measuring Cell Viability in Scaffolds

Ongoing
Project Goals Primary Goal: Advance measurements of cell viability in manufactured tissues Establish working group of industry stakeholders to guide work Develop model scaffold-cell-assay system for measuring cell viability in scaffolds Validate measurement system by orthogonal test methods Assess
Flow Cytometry Consortium

NIST Flow Cytometry Standards Consortium 

Ongoing
Advances in cell and gene-based therapeutics as well as other regenerative medicine products have increased the need for high quality, robust, and validated measurements for cell characterization. Flow cytometry, including imaging cytometry, has emerged as an important platform due to its ability to

NIST Genome Editing Consortium: Working Group 1 - Specificity Measurements

Ongoing
Genome editing technologies are able to produce DNA sequence changes of a variety of sizes and at a variety of frequencies in a population of edited cells. Having increased confidence in reliably detecting the sequences generated by a genome editing process was a need area identified. Project 1

NIST Genome Editing Consortium: Working Group 2 - Data & Metadata

Ongoing
Develop a metadata schema for genome editing experiments Develop a way of curating and entry that is low burden for user Release control data with linked metadata PROGRESS Phase1 metadata entries and templates completed In process of compiling and testing use cases, user interfaces, and

NIST Genome Editing Lexicon

Ongoing
The definitions are worded with the intention that additional context may be added with supplementary language when they are used. It is also recognized that genome editing is a rapidly evolving biotechnology and additional terms and definitions will be needed as genome editing technologies mature

NIST Rapid Microbial Testing Methods Consortium

Ongoing
The safety and quality of advanced therapies, including cell therapy, gene therapy, and tissue engineered products, must be maintained prior to patient administration. The culture-based compendial methods currently used to assess product purity (specifically to ensure absence of microbial

Orthogonal Measurements

Ongoing
Definitions: Orthogonal measurements: Measurements that use different physical principles to measure the same property of the same sample with the goal of minimizing method-specific biases and interferences. Complementary measurements: Measurements that corroborate each other to support the same

RMAT Laboratory Programs

Ongoing
Examples of Current Activities: Cell Counting and viability are key measurements critical for decision making from R&D to manufacturing. We recently developed an approach for evaluating the quality of cell counting measurements through experimental design and statistical analysis that does not

Single-Cell Manipulation and Measurement

Ongoing
Mammalian cells are an important source material for applications in regenerative medicine, gene therapy, engineering biology, and genome editing. Traditional tools for manipulating mammalian cells operate at a bulk cell population level without precision manipulation of individual cells
Research Grade Testing Material (RGTM 10212), Synthetic Fecal Metabolite Calibrant (Credit: NIST)

Synthetic Fecal Metabolite Calibrant Solution (RGTM 10212)

Ongoing
Metabolomics is an exciting and dynamic field in life sciences that harnesses cutting-edge technologies to identify and characterize small molecules, or metabolites, within cells, tissues, or organisms, collectively known as the metabolome. The wealth of evidence in the literature underscores the

U.S. TAG for ISO/TC276: Biotechnology

Ongoing
Get involved: Interested U.S. Stakeholders may participate in the US TAG at no cost. Membership provides access to all ISO/TC 276 and US TAG documents, including standards under development. Please click here to join. Contribute to standards development: Please click here to review, submit comment

Tissue Engineering

Ongoing
Tissue Engineering Measurands: Tissue engineering measurands are confusing to discuss and a charting method to improve communication is demonstrated. Measurement Assurance Strategies for Regenerative Medicine: Reliable methods for assessing product consistency and quality. Regenerative Medicine

Tissue Engineering Measurands

Ongoing
Making a Measurand Chart: A measurand chart can be created for any measurement by writing down all the measurands that occur during the measurement. The panels should not be procedural steps, such as “wash the sample with buffer” or “centrifuge the microfuge tubes”. Consider if the measurement has a