Synthetic genomics may be the most common dual-use biotechnology today. The ability to construct double-stranded DNA from scratch enables a better understanding of protein structure and function, and the development of new vaccines, speeding up the process of biological engineering. However, these technologies also have the potential to allow people with nefarious intentions access to toxins and pathogens that would be otherwise difficult to acquire.
With each passing year, synthetic biologists are becoming more adept at designing novel structures and functions from DNA, RNA, and proteins—the basic building blocks of biology. The Central Dogma of molecular biology is that DNA is transcribed into RNA, which is then translated into proteins (4). Proteins then perform a variety of functions inside and outside the cells. They can join together to build the cytoskeleton of the cell, break down molecules to produce the energy the cell needs, and much more. However, proteins can be also used to synthesize toxins such as cyanide salts and aflatoxins. Proteins can also themselves be toxins, such as ricin or Botulinum toxin.
These approaches even confer the ability to create viruses from scratch. In the past, DNA synthesis was a key step of the de novo (i.e., from scratch) synthesis of poliovirus, the 1918 influenza virus, and most recently horsepox virus. While the synthesis of an infectious virus requires a high degree of technical expertise, access to DNA was a bottleneck. For a ‘booted’ virus to be infectious, its synthesized DNA must have as few errors as possible. While benchtop synthesizers make it easier to synthesize double-stranded DNA without having to order a sequence from a gene synthesis company, this method typically leads to too many errors to make a long genetic sequence with high enough accuracy.
This potential threat can be reduced if gene synthesis providers screen their orders. Therefore, in 2010, the US department of Health and Human Services published the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA. This guidance recommends that companies screen both the customer and sequence of any gene synthesis order to ensure its legitimacy (13). However, since the publication of the HHS guidance, the gene synthesis industry has quadrupled in size, and the number of providers doubled. This once US-based industry is now growing, and is projected to keep growing, particularly in the Asia-Pacific region, where it was almost absent when the HHS guidance was written (14).
Here at the Johns Hopkins Center for Health Security we are currently mapping the gene synthesis industry in order to understand which changes are necessary for the future of the HHS guidance. We are searching for gene synthesis companies and cataloguing them based on their laboratory locations, the reach of their shipments, and the breadth of their screenings. We have published here a work-in-progress map with the hope of receiving feedback from the public and gene synthesis companies and ensuring the information we collected is correct.
If you would like to add a gene synthesis company to this map, or if you can verify information about a gene synthesis company’s laboratory locations, shipping, or screening protocols, please email Noga Aharony at email@example.com. We are assembling this information for publication, and will be making further recommendations regarding gene synthesis order screening.