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Area of interest: Biosecurity regulation for gene synthesis providers
What is the gene synthesis industry?
Biologists all over the world need specific DNA sequences for experiments and projects. Those sequences are provided by the rapidly growing gene synthesis industry. Customers send their desired genetic sequences as digital files to gene synthesis companies. Companies “print” the files into actual lengths of DNA (and other genetic material, like RNA), and ship them back to the customers. With actual genetic material, the customers can then insert their sequences into live organisms and biological systems.
Customers might invent their genetic sequences themselves, or might use sequences from the many published genomes available freely online. A couple decades ago, gene synthesis was prohibitively difficult and expensive for most scientists. It has become drastically cheaper over the past 15 years, and this service is now available to many end users.
Biosecurity relevance
Custom gene synthesis advances biotechnology and synthetic biology in numerous ways, and also raises major biosecurity risks: once a customer has a digital sequence from a pathogen or toxin, they could add this to an existing pathogen to make it more dangerous, or even to create a virus that they did not originally have. In 2016, a small group of Canadian researchers spent about six months and $100,000 dollars to create live horsepox virus (an extinct relative of the smallpox virus) using commercially synthesized genes.
Access to dangerous sequences is not a problem: the genetic sequences for Covid-19, Ebola virus, anthrax, smallpox, and virtually all other known human diseases are freely available online, hosted by the National Institutes of Health. The capabilities to manipulate these genetic sequences and insert them into live pathogens is also here now, and getting easier and cheaper all the time.
Getting these digital sequences synthesized into actual genes is the important step, and is where gene synthesis companies come in.
In short, the concern is that a malicious actor could purchase genes from a dangerous pathogen and use it to modify or even create an organism for use as a biological weapon. Current measures such as the Federal Select Agent Program regulate the sale and trade of complete pathogens and some genetic material, but at the time this program was established, there was no real chance that a pathogen could be assembled piecemeal from commercially ordered sequences. Now, we know that this can be done by a small team on a budget.
https://www.againstpandemics.org/research
The NIH’s genome library
https://www.ncbi.nlm.nih.gov/genbank/