The foundation of collaboration in synthetic biology may be cracking, specifically where development of bioethics standards for safety and security are concerned.

Synthetic biology’s de facto industry group, the International Association of Synthetic Biology (IASB), has been the major driver of such standards. Until recently, its efforts to develop standards for bioethics safety and security (BESS) culminated in a report released at a meeting in Munich in 2008. It had relied on what might be termed an open-source approach, using publicly available data as the basis for assessing risk. According to IASB guidelines, all incoming DNA sequence orders must be compared to the gene sequences stored at GenBank, the global online database that provides the most comprehensive repository of gene data. If a customer’s sequence completely or nearly matched a gene known to be pathogenic – a smallpox gene, for example – then a human subject matter expert (SME) would step in to evaluate the risk potential. The SME could then order a background check on the customer, contact a bioweapons expert through the IASB, or take other actions to ensure the legitimacy and safety of the customer’s research. The final guidelines were announced on November 3.

So far, so good. However, two leading gene synthesis companies, DNA2.0 and Geneart, broke with the IASB in November to form the International Gene Synthesis Consortium (IGSC) and promote their own set of standards. Blue Heron Biotechnology, GenScript and Integrated DNA Technologies have since joined them.

The IGSC is establishing a closed system, where members could draw on a database built on public sources like GenBank as well as proprietary data and other tools. In addition, IGSC’s model reduces or eliminates the manual SME work that the IASB method requires. Moreover, Geneart is the leader among a small group of companies – including Febit, Ginkgo BioWorks, Biosearch Technologies and Sutro Biopharma – that started a new industry group this month, the Synthetic Biology Industry Association (SynBIA). While the organization is only now communicating its mission, it claims it will collaborate with the IASB, and even endorse the IASB standard. Even so, it’s hard to see the move as an extension of the IASB, rather than a break.

So what’s behind the growing rift? To get one perspective, we spoke with Stephen Maurer of the Goldman School of Public Policy at the University of California Berkeley. Maurer, who helped the IASB develop its standards program, noted that the consortium claims its membership will be limited to “significant” companies, which means that a smaller number of more powerful organizations will be free to make decisions and move ahead without having to build broad consensus like the more inclusive IASB. Indeed, DNA2.0 underscores that the IGSC’s five members represent 80% of global gene synthesis capacity.

More importantly, the IGSC’s more automated approach would lower costs for members (at the expense of quality, Maurer argued), while smaller companies would still need to rely on slower, higher-cost human SMEs – or else join the standard without the benefit of a vote on its content.

Maurer added, “DNA2.0 has in the past told me that they consider the act of cross-checking the customer’s order to be reverse engineering” and a breach of customer trade secrets. However, he doesn’t see that current trade secret law actually requires this result, and that if companies want to take the extra trouble of having SMEs examine customer sequences by hand there is no legal reason why they cannot properly do so. Indeed, U.S. regulatory agencies like the Environmental Protection Agency (EPA) and Food & Drug Administration (FDA) regularly protect such confidential business information.

While this arguably minor point of contention among the nascent industry’s players could be dismissed as growing pains, the number and severity of disagreements evident in these actions indicate a major shift is underway. Firstly, the IGSC’s actions build competitive barriers to smaller companies entering the gene synthesis space. That counters the trend of advancing technologies that have lowered barriers of entry. Non-governmental organizations opposed to synthetic biology in principle are sure to seize the opportunity to portray the start-ups’ discord as evidence that self-regulation is not a viable option. Late last month, as if to warn the squabbling parties about the threat of government intervention if they don’t straighten up, the U.S. federal government reminded the world that it has its own BESS guidelines.

Clients interested in the synthetic biology space should expect this spat to be just the beginning of a tumultuous period, and can look forward to things getting worse before they get better for at least the next twelve months.

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