Five gene-synthesis companies have formed a consortium and established a set of common screening protocol to promote biosecurity in the gene-synthesis industry. By screening the sequences of synthetic gene orders and the customers who place them, the firms aim to support government efforts to prevent the misuse of gene-synthesis technology.
Blue Heron Biotechnology, DNA2.0, GeneArt, GenScript, and Integrated DNA Technologies have created the International Gene Synthesis Consortium (IGSC). Their “Harmonized Screening Protocol for Gene Sequence & Customer Screening to Promote Biosecurity” establishes five core components that each IGSC company will apply to promote the safe use of synthetic genes:
• Gene Sequence Screening: The complete DNA sequence of every synthetic gene order is to be screened against a regulated pathogen database developed by the consortium and one or more of the internationally coordinated sequence reference databanks. Amino acid sequences of possible translation products for each synthetic gene ordered will also be screened. All orders originating in the U.S. will also be screened against the U.S. Select Agent lists.
• Gene Customer Screening: A complete screening of each potential gene-synthesis customer will be conducted to establish identity and clearance for delivery of genes ordered in accordance with national guidelines.
• Record Keeping: The IGSC companies will keep all screening, customer, and order records for at least eight years.
• Order Refusal & Reporting: IGSC firms reserve the right to refuse to fill any order and to notify authorities upon identifying potentially problematic orders.
• Regulatory Compliance: IGSC companies comply with all applicable laws and regulations governing the synthesis, possession, transport, export, and import of gene synthesis and other products.
“There’s no single solution that solves all the problems in biosafety,” founder and CSO of Blue Heron Biotechnology, John Mulligan, Ph.D., pointed out to GEN. Hence the consortium has established this multilayered approach.
The founding companies together represent approximately 80% of the global gene-synthesis capacity. They bring over 10 years of experience and have tried and testing various internal-screening methods.
“It quickly became apparent to us when we started that gene synthesis not only had many potential benefits to biomedical research but also potential dangers,” Dr. Mulligan said. “Many companies and individuals would be able to gain access to potentially lethal pathogens where they otherwise would not have been able to. In thinking about the implications of gene synthesis, we wanted to make sure that we were not enabling any nefarious use of DNA.”
There are between 40 and 50 gene-synthesis companies worldwide. The hope is that over time additional firms will join the consortium to employ these voluntary screening guidelines and also provide further insights to fine-tune the screening protocol. “We see this as a starting point,” Dr. Mulligan added.
“By agreeing on common screening protocol, we can provide a model for regulation.” Currently, there are no regulations specific to the gene-synthesis industry. Instead these companies follow guidelines that pertain to all molecular biology researchers and companies.
Various national entities are also working to set up protocols, and the U.S. government is expected to publish guidelines before the end of this year, said Dr. Mulligan. “Our impression is that the harmonized screening protocols set up by the consortium will be consistent with the government’s.”