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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

Biomanufacturing

Projects/Programs

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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