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Health

Pharmaceuticals

Projects/Programs

Displaying 1 - 25 of 33
A schematic overview showing the distribution of the standardized samples to study participants, the use of standardized protocols for measurements, and standardized reporting of data back to NIST for analysis.

AAPS Interlaboratory Study: Protein Aggregation and Immunogenicity

Ongoing
To ensure the safety and efficacy of protein-based biotherapeutics, manufacturers strive to avoid unwanted immune responses caused by the biotherapeutic. Protein immunogenicity is a complex topic and depends on multiple factors related to the product, patient profile, and treatment. 1 , 2
Bioman lifecycle

Biomanufacturing Initiative

Ongoing
The objective of the NIST biomanufacturing program is to support US biopharmaceutical industry delivery of high quality and low cost protein drugs around the world. The mission is fulfilled through the development of standards, measurement science, and state of the art tools that support advances in
CLIA2

Cell Line Authentication

Ongoing
Cell Line Authentication – The scientific community has responded to the misidentification of human cell lines with validated methods to authenticate these cells; however, there are few assays available for nonhuman cell line identification. We have developed multiplex polymerase chain reaction (PCR

Combating Antibiotic Resistance

Ongoing
We are developing in vitro systems to generate controlled chemical and community environments that mimic the features of real-world that are important determinants for evolutionary rate and resistance potential. In addition, we are developing tools to isolate and analyze single bacteria along the
component 1

Consistency Analysis and Uncertainty in ‘omic Data

Ongoing
‘Omics is increasingly moving out of the laboratory and towards use in industrial and commercial applications. For instance, in biomanufacturing, there is a need for quality control when developing biotherapeutics, which will almost certainly require a machine-learning classifier to separate

Data Infrastructure for Biomanufacturing Process Control

Ongoing
Objective The objective of this project is to develop measurement science that includes ontology models, ontology expression (axiomatic) patterns, guidelines for qualifying those ontologies, and distributed ontology development software that will allow U.S. manufacturers to have better access to

ERCC 2.0: Developing a New Suite of RNA Controls

Completed
Requested RNA Control products include: Transcript isoforms; New and improved messenger RNA mimics and mixture formulations; microRNA and other small RNA molecules; and Cancer fusion transcripts. ERCC technical working groups are developing design specifications, RNA control products, and analysis

Fluid Suspensions and Emulsions

Ongoing
We aim to: Develop measurement capabilities to relate solution structure and viscosity through novel combinations of unique small volume, high shear rate rheometers with scattering and particle-imaging techniques. A major application of these capabilities is understanding self-association in fluids
13 tubes each containing an individual glycan in SRM 3655

Glycan Standard Reference Materials

Ongoing
Now Available A glycan-based NIST Standard Reference Material ( SRM 3655 Glycans in Solution) supports the biomanufacturing and protein therapeutics communities with a set of 13 individually-bottled, pure glycoforms including those most commonly observed as N-linked glycans on therapeutic monoclonal

HDX-MS for Biopharmaceutical Analysis

Ongoing
Intended Impact This project is designed to improve, test, and validate hydrogen/deuterium exchange mass spectrometry (HDX-MS) metrology for the determination of dynamical properties of therapeutic proteins and glycoproteins. Objectives Explore structure-function relationships between glycan

Improved Benchtop Connectivity to Complex Microfluidic Devices

Completed
Intended impact Microfluidic devices with many fluidic and pneumatic inlets are difficult to connect to benchtop reservoirs and controllers. Many hours can be spent sorting, untangling, and connecting tubing to a single device. If one then finds that the device is not fully functional, the process

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
NIST MS Search 2

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
Nanoparticle Metrology

Nanoparticle Metrology in Complex Cellular Environments

Completed
Nanoparticle interactions with individual cells. Existing techniques to evaluate nanoparticle incorporation include ICP-AES or ICP-MS, which atomize entire samples (thousands of cells) and detect nanoparticles by quantifying the elemental composition. Bulk techniques provide general trends averaged

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

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

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
Point-of-Care Pharmaceutical Manufacturing

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

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
Alex Rodriguez with data logger

Reliable Vaccine Storage

Completed
Our group examines best practices for the storage and monitoring of vaccines in partnership with the Centers for Disease Control and Prevention’s (CDC) Vaccine Supply and Assurance Branch. Vaccines are highly temperature sensitive, and inappropriate storage conditions can render them ineffective

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