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