With today’s biotechnology, we can use living cells as factories for products like food, fuels and medicines. Live cell and gene therapies, and regenerative medicine, are poised to revolutionize health care. Live microbial therapeutics are under development as the next class of clinical treatments. We can also make new kinds of sensors to rapidly detect disease outbreaks and biological weapons.
While the science of engineering cells has progressed, the American bioeconomy still struggles to design cell-based products from scratch and develop processes to manufacture them consistently at industrial scales. Unlike a traditional production line, living cells are always changing and difficult to control.
NIST scientists are addressing these issues by:
- working closely with industry to make measurement solutions for real-world development and manufacturing environments
- giving researchers and manufacturers measurement tools and methods they can use to compare and reproduce results, which speeds innovation, and ensure the product consistency needed to get clearance by regulators on the way to market
- helping researchers, manufacturers, regulators and clinicians make measurements that can be traced back to trusted NIST products, providing confidence in test results
- NIST’s human genome reference material, the first of its kind in the world, generated data that is accurate enough to be used as a benchmarking tool for medical and research labs. The U.S. Food and Drug Administration used this resource to approve one of the first commercially available next-generation DNA sequencers for clinical use.
- NIST now offers four additional human genome reference materials to help test labs assess their ability to measure genetic links within families, and compare and contrast genes from people with different lineages. These additional materials increase the confidence of DNA sequencing labs in reporting results, improving genetic tests used for disease risk prediction, diagnosis, and progression tracking. These reference materials also give companies reliable data to guide innovation in hardware, software and clinical research.
- NIST worked with more than 100 companies to characterize a monoclonal antibody reference material, known as the NISTmAb, that allows the biopharmaceutical industry to verify and improve their methods for quality control. Because its characteristics are so well known, the NISTmAb can also be used to evaluate new biomanufacturing methods and tools, accelerating innovation.
- A NIST-led consortium of more than 100 organizations from the public, private and academic sectors created the first-ever reference material for RNA. The reference material helps labs check the technical performance of their equipment, giving them confidence that they have reliable, reproducible measurements of the activity of genes, which influence our health and can be manipulated in other organisms to make commercial products. The reference material is used for product and method development, and quality control.
- Researchers from NIST patented the first DNA method for authenticating the mouse cell lines used for genetic research. The method enables better use of taxpayers’ investment in science by helping to provide assurance that cell lines are as labelled.