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Manufacturing

Biomanufacturing

Projects/Programs

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Organizational Unit

Live Cell Imaging of Induced Pluripotent Stem Cell Populations

Ongoing

As part of our program in Cell Biology , our live cell image program supports the advancement of induced pluripotent stem cell (iPSC) technology in three ways: 1) Identification of process control measurements: A critical component to the translation of iPSCs into therapeutic applications is to...

Cryogenic electron microscopy (cryo-EM) image of an LNP/RNA formulation

LNP-RNA Research Grade Test Material

Ongoing

The currently planned LNP/RNA material (designated RGTM 10240) will include a fragment of the SARS-CoV-2 genome that is approximately 4 kb in length. This fragment was previously included (in unencapsulated form) as “Fragment 1” of NIST RGTM 10169. The RNA fragment is not designed for cell-based...

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...

Measurements and Standards for AI-Ready Biological Data: Unlocking Protein Function

Ongoing

To address this need, the NIST Cellular Engineering Group is collaborating with the Align Foundation and several other laboratories to develop a framework of measurements and standards for AI-ready data. This framework is based on four principles designed to maximize the impact of data collection...

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...

Metrologies for Protein Structure, Dynamics and Function

Ongoing

Based on its established expertise, infrastructure, and resources for structure/function studies of biological macromolecules, the program aims to impact advances in physics, chemistry, and engineering relevant to biological problems. NIST researchers also develop new technologies for application to...

A micromechanical bulk acoustic resonator that uses phononic crystal tethers to achieve a quality factor approaching the fundamental dissipation limit (fxQ can be as large as 1.2 x 1013 Hz)

Micro- and Nanoelectromechanical Systems

Completed

MEMS/NEMS are enabling technologies that bring new functionalities with the potential to radically transform markets ranging from consumer products to national defense. The meteoric rise of the smartphone is an excellent example, in which MEMS accelerometers, gyroscopes, microphones, displays, and...

Microfluidic Synthesis of Nanoparticles

Ongoing

Liposomes have found many applications, including targeted drug delivery, immunoassay amplification, and medical imaging. For targeted drug delivery and medical imaging applications, the microfluidic-synthesis method could allow the synthesis of liposomes at the point of care, so that problems with...

Monoclonal Antibody Mass Spectral Libraries

Ongoing

Intended Impact Modern mass spectrometers used in the field of proteomics and glycomics are capable of profiling hundreds, and even thousands of molecules in a single experiment. Each of these compounds is isolated and fragmented to form a mass spectrum. Therefore, interpretation of these mass...

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

Ongoing

Targeted genome editing , a method used to alter the DNA of living cells at desired locations, is poised to revolutionize science and medicine. To fight diseases, novel genome edited therapeutics, including those for use in regenerative medicine and infectious diseases, are being developed. Many...

NIST Genome Editing Program

Ongoing

For genome editing systems to reach their full potential in research and commercial products, new measurement tools, capabilities, and standards must be developed to efficiently implement and assess the performance of these editing technologies, as well as to evaluate the utility of resulting...

NIST LabCAS: Data Driven Science Architecture and Resource

Ongoing

Biological data lie at the heart of innovation and artificial intelligence (AI) advances in the emerging biotechnology sector and serve as key strategic resources for achieving major breakthroughs in biomanufacturing, as summarized by the National Security Commission on Emerging Biotechnology's...

NISTmAb RM8671 vial and 3D printed model

NIST Monoclonal Antibody Reference Material 8671

Ongoing

The NISTmAb material is a recombinant humanized IgG1κ expressed in murine suspension culture. It is an »150 kDa homodimer of two identical light chains and two identical heavy chains linked through both inter- and intra-chain disulfide bonds. The protein has low abundance post-translational...

NIST PS1 Primary Standard for quantitative NMR (Benzoic Acid)

Completed

With explicit SI linkage, the overall impact of this apical reference material is profound—this primary standard, as well as forthcoming members of its class, provides technology transfer of chemical purity realization to the commercial sector for characterization of many thousands of organic...

Box for NISTCHO in center, vial of NISTCHO to the right

NISTCHO: Monoclonal Antibody Producing Cell Line

Ongoing

NISTCHO, a new mammalian cell line of interest to the biopharmaceutical and biomanufacturing communities, is now available from the National Institute of Standards and Technology. This Chinese hamster ovary (CHO) cell line has been engineered by MilliporeSigma to express a non-originator version of...

Optical/electrical particle measurement system

Completed

Intended Impact The results of this work should provide instrument manufacturers with data, methods, and algorithms for enhancing the clarity and accuracy of information their instruments provide to their customers. Users of these instruments (pharma companies) and regulators, will have better...

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...

Pathogen Detection and Identification: The Next Generation of Analyses

Ongoing

Human disease resulting from pathogens represents a tremendous burden on the health care system. Many hospitals have adopted new, rapid polymerase chain reaction (PCR)-based detection systems because the time to diagnose and begin effective treatment has a direct impact on patient survival and...

Photonic Dosimetry

Ongoing

With this effort, NIST is responding to industry needs for traceable, measurement solutions that can resolve spatial variations of absorbed dose at the level of individual components on a silicon wafer or bacteria on surgical instruments. Presently, there is only limited traceability to national...

Point-of-Care Pharmaceutical Manufacturing & Precision Medicine

Ongoing

We are employing quality by design (QbD) and risk assessment (cause-and-effect) approaches to investigate production technologies ( e.g., drop on demand or inkjet printing platforms) and appropriate analytical control strategies for point-of-care manufacture of narrow therapeutic index drugs...

Polyelectrolyte Solutions and Gels

Ongoing

Polymer Advanced Manufacturing and Rheology

Ongoing

The manufacture of polymeric materials, whether from virgin or reclaimed sources, occurs under highly non-equilibrium conditions where temperature and stress fields evolve rapidly. The quality of the materials made from these processes depends not only on the composition of the starting material...

Predicting stability of nucleic acid biopharmaceutical products using advanced computational modeling techniques

Ongoing

Modified oligonucleotides increase efficacy of nucleic acid drugs. These modifications impact degradation resistance, enhance thermodynamic stability, and render oligonucleotides unrecognizable to the immune system. However, not much is known about how these chemical modifications affect structure...

Protein Preservation

Completed

This project is an integral part of a cooperative effort – led by NIST, and partially funded by NIH/ NIBIB – which includes the University of Wisconsin, the University of Colorado, and the University of Connecticut. We use the following approach to develop measurement solutions for biopharmaceutical...

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