Projects/Programs

Displaying 1 - 25 of 61

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

Advanced Data Exchange Standards for the Biomanufacturing Supply Chain

Ongoing

Objective The objective of this project is to develop measurement science that includes methods, workflow models, information meta-models, interoperability metrics, and prototype tools to help U.S. manufacturers reduce the time and cost associated with making supply chain data accessible for better

Assay Development for Cell-Free Expression Systems

Ongoing

Current practices for characterizing cell-free expression systems are limited and unsuitable to advance these technologies beyond the state-of-the-art. To meet this measurement need, the Cellular Engineering Group is developing quantitative assays to benchmark cell extracts, reagents, and cell-free

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

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

Cell Counting for Cell Therapies

Ongoing

Recent Publications and Resources for Cell Counting and Related Measurements Tools NOW AVAILABLE : COMET (Counting Method Evaluation Tool) , A Shiny Application that executes the statistical analysis and reporting outlined in ISO 20391-2:2019 https://cell-counting.shinyapps.io/COMET/ Standards ISO

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

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

Chinese hamster ovary (CHO) cell line authentication

Ongoing

Intended impact To develop a PCR based multiplex assay that can be used to authenticate Chinese hamster ovary cell lines which are important in the production of biological therapeutics. Objectives Identify tetranucleotide STR markers by searching the CHO genome using BLAST Design and optimize a

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

Development of a Collagen Fibril Reference Material for Reproducible Cell Response

Ongoing

Research is ongoing to assess what information is required to validate films of collagen as reference extracellular matrix. During the first portion of this work we will develop protocols for characterizing the prototype collagen reference material with various instrumental techniques to develop

Development of the NIST Prototype Advanced Biometrology Laboratory

Ongoing

Currently, NIST is investing in a new type of metrology laboratory that is focused on the unique reference material and high quality assay protocols that are needed in the regenerative medicine and biotechnology communities. The laboratory design is centered on automation that can set up 1000’s of

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

External RNA Controls Consortium

Completed

While early gene expression measurements with DNA microarrays were groundbreaking in their ability to reveal biological activity, the results were irreconcilable and irreproducible. Industry leaders approached the National Institute of Standards and Technology (NIST) in 2003 for help with addressing

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

viral vector illustration with RNA seen within the capsid

Gene Delivery Particle Analysis with High-Throughput Light Scattering Microscopy

Ongoing

This project aims to develop light-scattering microscopy methods for rapid, multi-attribute characterization of gene therapy particles at the single particle level. Emerging gene therapy treatments use gene delivery particles, such as viral vectors and non-viral carriers, to cure intractable

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

High-Sensitivity IR Spectroscopy of Proteins

Ongoing

Infrared (IR) absorption spectroscopy has been widely used as a non-invasive, label-free characterization method for the chemical identification and structure of complex biomolecules. Fourier-transform IR (FT-IR) technology is commonly used to characterize proteins and other biological molecules

Integrated Lentiviral Vector Copy Number Measurements: Invitation to Participate in an Interlaboratory Testing Program Evaluating Genomic DNA Test Materials

Ongoing

NIST has produced genomic DNA test materials from transduced Jurkat cell lines with integrated lentiviral vector copy number (VCN) for evaluation as a candidate reference material. Transducing Jurkat (Clone E6-1) cell lines with a lentivirus expressing a green fluorescent protein were produced by

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

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

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