New technologies create opportunities for scientific breakthroughs, address pressing challenges, and improve our quality of life. At the same time, every technological advance carries a risk of being misused or causing unforeseen problems even when it’s applied with good intentions. As we enter a new era of biological engineering with tools like Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) editing making genomic manipulation easier than ever before, we have to ensure that proper frameworks are in place for the safe use of these powerful technologies.

At Inscripta, we care about biosecurity and strive to be a thought leader in the field. We wanted to highlight two recent articles we came across that examine the challenges of biosecurity in the context of CRISPR and gene editing. The first, “Building biosecurity for synthetic biology” published in Molecular Systems Biology, discusses the broad implications of genetic engineering and proposes guidelines for establishing risk assessment procedures. The second, “CRISPR Cautions: Biosecurity Implications of Gene Editing” in Perspectives in Biology and Medicine, focuses specifically on CRISPR as an emerging technology. Here are a few takeaways from these papers.

Preemptive biosecurity measures can help avoid undesirable consequences

The first article, prepared by a group of US and European scientist, calls attention to potentially unforeseen adverse outcomes of genetic editing, including off‐target effects, spread of gene‐edited material in the environment, and the impact of genetically altered organisms on ecosystems.

To avoid these undesirable consequences, the authors encourage research institutions and labs to be proactive and see development of biosecurity measures as an investment rather than an added cost. “Long‐standing biosecurity policy practices appear to have gaps in biosecurity oversight for [synthetic biology]. These policies include the framing of security as a cost or undesirable expense,” the Molecular Systems Biology article says. They advocate for an open dialogue between scientists, biosecurity experts, and policy analysts at the early stages of research.

Creating gatekeeping systems to prevent deliberate misuse

As gene editing tools are becoming more widely available, cheaper, and easier to use, there is higher risk of deliberate misuse by bad players: “Currently, significant barriers remain for independent actors to access critical equipment and materials, but oversight organizations are not prepared for a future when intangible transfers reduce or overcome these obstacles,” warn the authors of the paper cited above.

Screening measures are proposed for every stage of the process. For instance, DNA synthesis can serve as a gatekeeping step for genetic editing. DNA synthesis is typically outsourced to specialized companies who have stringent screening measures in place designed to detect sequences that could be misused. It is estimated that up to 80% of DNA synthesis is currently done by entities that are part of the International Gene Synthesis Consortium (IGSC) formed to design protocols for screening sequences and customers.

However, benchtop “DNA printers” are becoming a widely available technology, making it more difficult to monitor the activity of all industry players and every step that impacts final synthetic biology product. Hence, it is important to have multiple mechanisms for monitoring user activity. At Inscripta, we have developed multi-step screening procedures for all users and edit designs to ensure the highest safety standards.

Raising awareness and providing biosecurity training

As the second article’s authors point out, scientists are the most familiar with the current limits and potential of gene editing technologies. However, they are often unaware of potential ways these technologies can be misused. This is why providing historic and legal education, engaging scientists in discussion on ethics and biosecurity concerns, and their engagement in policy making is so important.

Organizations like the International Genetically Engineered Machine (iGEM) promote increasing wider participation and engagement in bioengineering while maintaining rigorous standards for the review of materials and planned experiments of participating teams. iGEM’s Safety and Security Committee (SSC) provides screening by a commercial partner and biosecurity guidance for participating students.

Improving access while maintaining safety and global communication

Both articles also address the issue of democratizing engineering biology. CRISPR is making genome editing technologies widely available in research and commercial laboratories around the world. While it is difficult to establish universally accepted international protocols, an ongoing global dialogue is highly encouraged:

“There is a growing demand for an update to international biosecurity norms and practices akin to the Cartagena Protocol on Biosafety, to increase transparency, cooperation, and collective security in pursuit of [synthetic biology].” The global non-profit Nuclear Threat Initiative (NTI) is making strides to develop and promote biosecurity norms that support global biotechnology innovation and protect against potential harm.

Here at Inscripta, we are engaging the genome engineering community to strategize a collaborative path forward to address biosecurity needs. This effort is leveraging outcomes of previous gatherings, such as a Biosecurity Practices and Opportunities workshop led by Inscripta’s contractor, Sarah Carter, and an Editing Biosecurity study co-led by collaborator Megan Palmer. As Inscripta takes a lead in upholding safety and responsibility in genome engineering, we aim to help ensure the technology continues to thrive as it advances and democratizes.

Read the two articles here and here.