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Manufacturing

Projects/Programs

Keyword

Organizational Unit

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...

Synthetic Biology

Ongoing

New measurement methods and tools are required for biology to emerge fully as an enabling, practical platform for engineering. The Cellular Engineering Group works to provide a foundation of measurement assurance to support the control and rational design of biological function. Through state of 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...

Thermodynamic Principles Describe and Predict Cell Populations

Ongoing

Heterogeneity of cell populations indicates the many ways cells can process information. We study heterogeneity in gene expression by inserting a gene for a fluorescent protein downstream of the gene we are interested in, and we examine large numbers of cells by imaging or flow cytometry. We think...

Thermodynamics of Enzyme-catalyzed Reactions

Ongoing

Current efforts are focused on industrially important biotransformation problems such as those found in hydrogenation, hydroxylation, aromatic amino acid metabolic pathways, and biofuel applications. The methods used include calorimetry, chromatography, enzymology, and spectrophotometry. The...

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...

Unfolding and Aggregation of Therapeutic Proteins

Completed

A stable protein formulation is essential to the safety of mAb drugs. In particular, mAb drug solutions formulated at high concentrations can undergo various biophysical instabilities, such as aggregation and liquid-liquid phase separation. These undesired solution properties are primarily driven by...

Validating A.I. Pipelines for Analysis of Live Cell Image Data

Ongoing

We are exploring methods for very high-speed cell image data collection, which is enabling the repeated sampling of thousands of cells every 2 minutes. Rapid sampling allow us to observe dynamic processes in cells (such as cell division) on a relevant time scale. Such rates of sampling allows us to...

WG1 Terminology

Ongoing

Standard(s) Under Development: ISO/WD TR 20386 Inventory of biotechnology-related terms US TAG WG1 Expert: Sumona Sarkar TAG Administrator: Clare Allocca

WG3 Analytical Methods

Ongoing

Standard(s) Under Development ISO/WD 20391-1: Biotechnology - Cell Counting – Part 1. General Guidance on Cell Counting Methods ISO/WD 20391-2: Biotechnology - Cell Counting – Part 2. Experimental Design and Statistical Analysis to Quantify Counting Method P erformance ISO/AWI 20395: Quality...

WG4 Bioprocessing

Ongoing

Standard(s) Under Development: ISO/AWI TS 20399-1: Raw materials control for bioprocessing -- Part 1: General definitions and requirements for quality control ISO/AWI TS 20399-2: Raw materials control for bioprocessing -- Part 2: Best practice guide for supplies ISO/AWI TS 20399-3: Raw materials...

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Biomanufacturing

Projects/Programs

Protein rheology measurements

Prototype Cell Assay Measurement Platform (P-CAMP)

Quantitative Flow Cytometry Measurements

Quantitative, Traceable Determination of Cell Viability Using Absorbance Microscopy

RMAT Laboratory Programs

Serology and Neutralization Assays for COVID-19

Storage Stability of Freeze-Dried Proteins

Surrogate protein particle standards

Synthetic Biology

U.S. TAG for ISO/TC276: Biotechnology

Thermodynamic Principles Describe and Predict Cell Populations

Thermodynamics of Enzyme-catalyzed Reactions

Tissue Engineering

Tissue Engineering Measurands

Unfolding and Aggregation of Therapeutic Proteins

Validating A.I. Pipelines for Analysis of Live Cell Image Data

WG1 Terminology

WG3 Analytical Methods

WG4 Bioprocessing

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