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Manufacturing

Biomanufacturing

Projects/Programs

Keyword

Organizational Unit

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

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

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

NISTCHO

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

Ongoing

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

Materials Extrusion Additive Manufacturing

Polymer Advanced Manufacturing and Rheology

Ongoing

We are measuring the fundamental processes and material parameters that are critical to understanding and furthering polymers-based AM. These efforts will aid the AM ecosystem through better online monitoring capabilities and developing strategies for materials optimization. In situ measurements of

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

Protein rheology measurements

Ongoing

Intended Impact Why does the health-care industry care about rheology and scattering of protein solutions? Operations. Viscosity is a critical and fundamental constitutive input for drug delivery, device design and manufacturing. For example, high viscosity leads to poor syringeability due to high

Prototype Cell Assay Measurement Platform (P-CAMP)

Ongoing

A systematic approach to the development of robust biological assay includes identifying and ranking the sources of variability in an assay protocol. With a focus on mammalian cellular assays, the Prototype Cell Assay Measurement Platform ( P-CAMP) laboratory was designed and built to take advantage

Quantitative Flow Cytometry Measurements

Ongoing

Flow cytometry is an essential tool for: basic biotechnological and immunological research, the clinical discovery of potential therapeutics, development and approval of drugs and devices, disease diagnosis, and therapeutic treatment and monitoring For example, flow cytometry is commonly used in pre

Quantitative, Traceable Determination of Cell Viability Using Absorbance Microscopy

Ongoing

The current gold standard for cell viability measurements is the trypan blue assay. Trypan blue dye enters dead cells that have a ruptured membrane. As a result, the dead cells are stained blue. Live cells with an intact membrane, on the other hand, do not absorb the dye molecules and remain

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

Serology and Neutralization Assays for COVID-19

Ongoing

Multiplexed bead-based SARS-CoV-2 serological assay We have developed a validated multiplexed bead-based SARS-CoV-2 serological assay that measures different antibodies produced by a patient (IgG, IgM, IgA). In collaboration with the NIST Applied and Computational Mathematics Division, we have

Storage Stability of Freeze-Dried Proteins

Completed

Intended Impact Work in this project will enable industry to develop rational formulation approaches for freeze-drying, thus facilitating the manufacture safer, longer lasting biopharmaceuticals, with less time and resource cost required for stabilization. Biopharmaceuticals are the fastest growing

Surrogate protein particle standards

Ongoing

Intended Impact This work will enable industry to obtain accurate, reproducible counts of protein particles, and to differentiate protein particles from other particle types, resulting in greater drug efficacy and safety. Objectives Create a polydisperse suspension of polymer particles that mimic

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