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Projects/Programs

Displaying 26 - 35 of 35

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

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

Synthetic Fecal Metabolite Calibrant Solution (RGTM 10212)

Ongoing
Metabolomics is an exciting and dynamic field in life sciences that harnesses cutting-edge technologies to identify and characterize small molecules, or metabolites, within cells, tissues, or organisms, collectively known as the metabolome. The wealth of evidence in the literature underscores 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

Tandem Mass Spectral Library

Ongoing
Intended Impact Modern mass spectrometers commonly generate ions by electrospray mass spectrometry which are separated and then fragmented by collisional dissociation. This process yields fragment ion ‘fingerprints’ (or mass spectra) that are widely used to identify the individual components in a

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