The field of synthetic biology has enormous potential for constructively impacting society, already contributing products such as drugs, food ingredients, and living fertilizers. As the field continues to develop, standardization of synthetic biology tools, techniques, and processes could help realize that potential. The rapid growth of the semiconductor industry in the 20th century, and its push for standardization, serves as a potential model for the synthetic biology industry. This idea was explored during a late April hearing held by the Senate Commerce, Science, and Transportation Committee, convened to discuss the nomination of Dr. Eric Lander to be director of the Office of Science and Technology Policy.
The potential of synthetic biology
It is critical for the U.S. to continue to lead in synthetic biology. Synthetic biology has the potential to revolutionize many sectors, such as healthcare and agriculture. For example, researchers are working to engineer immune cells to treat cancer, correct defective genes, and optimize antibody and vaccine production. In agriculture, synthetic biology could be used to optimize plants’ ability to use nitrogen and phosphorus, decreasing the amount of chemical fertilizer necessary, or to increase the nutritional value of foodstuffs. Policymakers recognize the potential of synthetic biology; for instance, the discipline is listed as a key research priority in the Endless Frontier Act, and is the primary focus of a separate bipartisan bill that aims to support U.S. synthetic biology.
During the hearing, Dr. Lander suggested (1:06:05) that to make synthetic biology technologies accessible to even more innovators, the federal government should play a role in creating and disseminating synthetic biology “toolkits,” as well as sharing best practices for their use. Dr. Lander related this to the early stages of working with semiconductor toolkits and assembling integrated circuits. Standardization contributed to the advancement of the semiconductor industry, and to take full advantage of synthetic biology’s potential, standards, and standardization, could play a role. Setting standards allows for exact measurements and more precise communication between researchers. For synthetic biology specifically, standardization would support the ability to scale production and take on even more complex tasks. Some of the challenges surrounding standards are the possibility that standardization could reduce researchers’ flexibility and creativity, as well as identifying which systems or processes should be standardized, and successfully deciding on what those standards should be.
Many standardization attempts in synthetic biology have been focused on bacteria because they are generally more easily engineered than other types of cells, and they can produce valuable compounds for both research and industrial uses. Cell-free systems, where components of interest are produced artificially or extracted or enriched from other cells and then refined in vitro, have been successfully standardized, but unfortunately, these systems lack the ability to scale or produce important substances without human intervention. Some areas that researchers are looking to standardize further include the design of strands of DNA, and the production of data and biosystem models.
One federal agency, the National Institute for Standards and Technology (NIST), is already working on establishing standards in synthetic biology. NIST is currently working with researchers and manufacturers to develop measurement tools to help compare and reproduce scientific results. One accomplishment was to produce human genome reference materials to help compare the genes of people with different lineages, increase confidence in DNA sequencing, and improve genetic tests. NIST has also helped develop reference materials for monoclonal antibodies and RNA, as well as developed the first method to use DNA to authenticate mouse cell lines used in genetic research.
Standardization would help improve communication between researchers, and quality assurance across the field. The act of standardizing research processes and manufacturing has aided many other industries before, and, as Dr. Lander referenced, one of those is the semiconductor industry.
Semiconductors and standardization
The advent of semiconductors, which are now critical to electronic devices, began in the early 1800s, and research and development continued into the 1900s. A semiconductor is a material whose ability to conduct electricity falls between that of a conductor, such as most metals, and an insulator, such as rubber or glass. Unlike most metals, whose ability to conduct electricity decreases as they get hotter, semiconductors improve their electrical conductivity as they increase in temperature. A large number of semiconductors are made of silicon, though there are other materials, like germanium and gallium arsenide, used as well. Their unique properties make semiconductors extremely important in all modern electrical devices.
When first developed, semiconductors were not standardized. By 1972, there were more than 2,000 different specifications for silicon semiconductor wafers. One of the major industry organizations, the Semiconductor Equipment and Materials International (SEMI), decided to develop standards for semiconductors and published its first book of these standards in 1978.
These SEMI standards are developed through a network of small volunteer task forces. When a new standard needs to be devised, a task force is created with volunteers from SEMI’s industry member organizations. Any proposed standards are reviewed and voted on by the entire membership. If there are any negative votes, open forum meetings are convened to discuss why those organizations opposed the standards, additional evidence is presented, and if the opposition is considered persuasive, the proposed standards are sent back to the task force for revision. Only after all negative votes have been considered and addressed are the standards approved. All standards developed by SEMI are re-evaluated every five years to ensure they remain up to date.
There have been many benefits to standardization in the semiconductor industry. For example, standardizing the sizes of semiconductors allowed manufacturers to focus on ways to decrease production costs and increase performance without having to devote a substantial amount of time to the fabrication process. Furthermore, measurement standards have allowed scientists to efficiently build upon past research, obtain follow-on funding, and work toward commercialization of new semiconductor technologies.
Synthetic biology will contribute to important advances in medicine, agriculture, and numerous other sectors in the coming years. However, there are still questions as to how to develop standards that allow researchers to more effectively compare data, reproduce results, and create products. The semiconductor industry can be a useful example of how standardization aided the rapid growth of an industry that has revolutionized people’s lives. As different legislative initiatives make their way through the congressional policymaking process, the discussion around synthetic biology standards will only become more necessary. We encourage the CSPI community to serve as a resource to Congress and the federal government in this area as we monitor for future policy developments.