NIST’s Role in the Bioeconomy

Credit: Adobe Stock / reconfiguration N. Hanacek

What is the Bioeconomy?

The bioeconomy encompasses economic activity resulting from biology-based products and processes. Such practices can 

• decrease reliance on fossil fuels by using plants rather than oil as feedstock for fuels, and textiles and plastics, which further benefit the environment by degrading harmlessly once used
• increase crop yields without use of chemical fertilizers by encouraging growth of beneficial microorganisms in the soil
•  sense and clean up environmental contaminants with engineered bacteria
•  provide cell-based therapies for autoimmune disorders, cancers, and other diseases that have otherwise resisted treatment

Biology-based technologies are part of an enterprise that generated nearly $400 billion in revenue in 2017, accounting for 2% of the U.S. gross domestic product.  

NIST’s Role

The White House Office of Science and Technology Policy has declared promoting and protecting the bioeconomy as a research and development priority for 2021. Agencies like NIST are directed to “focus on R&D that enables biotechnology, 'omics, scientific collections, biosecurity, and data analytics to drive economic growth across multiple sectors including healthcare pharmaceuticals, manufacturing, and agriculture.”

NIST provides the measurement science, validated data, and standards development leadership to support the maturation of new biotechnologies into successful products. For example:

• We are America’s National Metrological Institute, providing measurements and reference materials that are traceable back to SI units, the international standard for measurements. This trail of measurement assurance gives buyers throughout the biotechnology supply chain confidence in components. 
• Our reference materials help manufacturers assess the quality of their processes: If they test one of our reference materials and don’t get values that match ours, they know to check their equipment calibrations or test methods.
• We provide technical advice to industry bodies on the development of documentary standards. Standards help to ensure that products are safe, reliable, and interoperable, and they advance  innovation: Standards define the parameters of success and give smaller companies an opportunity to develop pioneering components or methods that fit into the larger manufacturing process. 

As we advance the state of the art in measurement science, we also support innovation in established industries. For example, monoclonal antibody therapies, which are produced by genetically modified cells, harness the body’s immune system to treat cancers, autoimmune disorders, and infectious diseases. Although the market for these therapies is growing fast—global revenue from monoclonal antibody products is expected to surpass $218 billion by the end of 2023—controlling the quality of monoclonal antibodies during production has been a long-time challenge, costing manufacturers time and money. 

Biopharmaceutical companies asked NIST to create a reference material they can use to verify and improve their methods for quality control. We worked with more than 100 companies to characterize the material, now known as the NISTmAb, using a variety of analytical methods employed by industry. Because its characteristics are so well known, the NISTmAb can also be used to evaluate new biomanufacturing methods and tools, accelerating innovation. The NISTmAb is one of the top-selling Standard Reference Materials, and is used by both large and small companies.

In addition, measurement tools like the NISTmAb can inform regulatory decisions and will help enable the development and approval of new biopharmaceuticals and lower-cost generic versions, so-called biosimilars, thereby allowing more Americans greater access to these life-saving medicines.