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Biosecurity in the Age of Synthetic Biology: Safeguarding Against Emerging Risks

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05 Jul 2024

11 Min Read

Dr Lee Khai Wooi (Academic Contributor), The Taylor's Team (Editor)

IN THIS ARTICLE

In recent years, the field of synthetic biology has witnessed remarkable advancements, revolutionising our ability to engineer and manipulate biological systems. From designing organisms that can produce life-saving drugs to developing sustainable biofuels, the potential benefits of synthetic biology are vast and transformative. However, as with any powerful technology, these advancements come with significant risks that must be carefully managed.

 

The concept of biosecurity has never been more relevant. The rapid pace of innovation in synthetic biology has opened a proverbial Pandora's box, unveiling a spectrum of biosecurity challenges that were previously unimaginable. The dual-use nature of synthetic biology—where the same technologies that offer great benefits can also be misused for harmful purposes—presents a complex and urgent dilemma.

Understanding Synthetic Biology

Synthetic biology is an interdisciplinary field that combines principles from biology, engineering, and computer science to design and construct new biological parts, devices, and systems. Unlike traditional genetic engineering, which modifies existing organisms, synthetic biology aims to create entirely new organisms or redesign existing ones to perform novel functions. This field leverages advancements in deoxyribonucleic acid (DNA) synthesis, genome editing, and computational modelling to achieve precise and predictable modifications at the genetic level.

 

Potential applications of synthetic biology are vast and varied. In medicine, synthetic biology is being used to develop new therapies, including engineered cells that can target and destroy cancer, or microorganisms that produce vital pharmaceuticals. In agriculture, synthetic biology can create crops that are more resistant to pests and diseases, tolerant to drought, or have enhanced nutritional profiles. Environmental applications include designing bacteria that can clean up pollutants or valorise waste into valuable resources.

DNA test sequence for research and science

Recent Advancements for Synthetic Biotechnology

One of the most groundbreaking advancements is the development and refinement of CRISPR-Cas9, a powerful genome-editing tool that allows scientists to make precise changes to DNA with unprecedented ease and accuracy. Building on this, researchers have developed CRISPR-based gene drives, which harness the principles of Darwinian evolution and natural selection to spread genetic changes rapidly through populations of organisms. These gene drives can propagate desired traits with greater efficiency than would occur through normal inheritance, offering potential solutions for controlling vector-borne diseases like malaria by promoting the spread of genes that either reduce the ability of mosquitoes to transmit the disease or decrease their population size.

 

In the realm of synthetic genomics, the creation of synthetic minimal cells has been a monumental achievement. In 2016, scientists at the J. Craig Ventre Institute successfully synthesised a minimal bacterial genome, demonstrating the potential to build custom organisms tailored for specific tasks.

Modern microscope equipped with a digital camera, computer and monitor in a biological research laboratory

Another significant advancement is the development of synthetic biology circuits that enable the programming of cellular behaviours. These genetic circuits can control gene expression in response to environmental signals, leading to applications such as smart therapeutics that release drugs in response to specific biomarkers or environmental biosensors that detect and neutralise pollutants.

 

At the same time, the field has seen remarkable progress in the synthesis of complex biomolecules. For example, synthetic biologists at MIT have engineered yeast to produce antimicrobial peptides, which can serve as potent antibiotics. This method offers a sustainable and scalable approach to antibiotic production, reducing reliance on traditional synthesis methods. Similarly, synthetic biology has enabled the production of bio-based chemicals and materials, such as spider silk produced by genetically engineered yeast, which holds promise for sustainable manufacturing.

A small spider wove a web in the forest

In synthetic biology, metabolic engineering is used to reprogramme metabolic pathway within cells. Advancements in this area have led to the production of valuable biomaterials such as synthetic fuels and plastics, offering sustainable alternatives to fossil fuels and conventional plastics. Engineered microorganisms, such as bacteria, yeast, and algae can be programmed to convert biomass, including agricultural waste into high-value products like ethanol, butanol, and bioplastics.

 

Breakthroughs in the production of bioplastics, such as polylactic acid (PLA) and polyhydroxyalkanoates (PHA), have shown promise in creating biodegradable and compostable materials that can reduce plastic pollution. For instance, a 2022 collaborative study between researchers from China and the UK successfully engineered E. coli to produce PHA with high efficiency, showcasing a scalable method for sustainable plastic production.

 

Finally, synthetic biology is making strides in the development of advanced therapeutics. Researchers have engineered bacteria capable of residing in the human gut and producing therapeutic compounds in situ, exerting immunoregulatory effects to combat diseases such as inflammatory bowel disease and cancer. The use of synthetic biology in immunotherapy is showing promise, with engineered cells designed to enhance the body's immune response against cancer cells.

 

Recent advancements include the development of CAR-T cells, which are genetically modified to express chimeric antigen receptors (CARs) that target and kill cancer cells more effectively. In 2023, a breakthrough study reported on the successful engineering of CAR-T cells to overcome the immunosuppressive microenvironment of solid tumors, leading to improved survival rates in preclinical trials.

CAR-T Cell Therapy Targeting Cancer Cells

Emerging Risks in Synthetic Biology

The concept of dual-use technology refers to scientific advancements that can be used for both beneficial and harmful purposes. In synthetic biology, this dilemma is particularly pronounced. The same techniques that enable the creation of life-saving drugs or environmentally friendly biofuels can also be misused to develop biological weapons or harmful organisms. This dual-use nature necessitates stringent oversight and regulation to ensure that the positive applications of synthetic biology are maximised while minimising the potential for misuse.

 

 

Bioterrorism
 

The intentional creation and release of harmful organisms designed to cause widespread harm or disruption. Synthetic biology could potentially be used to engineer pathogens with enhanced virulence or resistance to existing treatments.

Storage of yellow bins with radioactive and chemical hazard symbol
Accidental Release

 

The unintentional release of living modified organisms (LMOs) into the environment, which could disrupt ecosystems or spread unintended traits to wild populations. This risk is heightened by the increasing ease and accessibility of synthetic biology tools.

Close-up scientist or environment engineer's hand with a chemical protective suit and PPE collect a sample of toxic wastewater from a chemical flask

Real-Life Examples of Biosecurity Challenges

The ethical implications of creating synthetic organisms, including concerns about human intervention in natural processes, the potential for unforeseen consequences, and the moral responsibility of scientists and engineers in the field. These concerns also extend to issues of biohacking and the democratisation of powerful biotechnologies.

 

 

The 2001 Anthrax Attacks

 

In the aftermath of the September 11 attacks, letters containing anthrax spores were sent to several news media offices and two Democratic Senators in the United States, resulting in five deaths and multiple infections. This bioterrorism event underscored the potential misuse of biological agents and highlighted the critical need for robust biosecurity measures.

Image of Anthrax Letter Sent to Senator Leahy

Image of Anthrax Letter Sent to Senator Leahy, Public Domain. Retrieved from FBI Media.

The StarLink Corn Incident

 

In 2000, StarLink corn, a genetically modified strain approved only for animal feed due to concerns about allergenicity, was found in the human food supply. This incident sparked a major controversy, leading to widespread recalls and highlighting the challenges of controlling living modified organisms (LMOs) once released.

 

 

The Synthesis of Horsepox Virus

 

In 2017, researchers in Canada synthesised the horsepox virus from scratch, demonstrating the feasibility of recreating extinct pathogens. While the research aimed to develop better and safer vaccines for smallpox, it raised significant biosecurity concerns about the potential recreation of smallpox, a deadly human pathogen eradicated in the 20th century.

 

 

The H5N1 Avian Influenza Studies
 

In 2011, researchers in the Netherlands and the United States modified the H5N1 avian influenza virus to make it transmissible between ferrets, a model for human influenza transmission. The studies aimed to understand the virus's mutation potential, but the creation of a more contagious form of the virus sparked widespread debate over the risks of such research and the potential for accidental or intentional release.

ntelligent breeding farm for laying hens

Current Biosecurity Measures

Regulatory frameworks at both international and national levels play a critical role in governing synthetic biology to ensure biosecurity. Internationally, the Biological Weapons Convention (BWC) prohibits the development, production, and acquisition of biological weapons. The Cartagena Protocol on Biosafety, part of the Convention on Biological Diversity, specifically addresses the safe transfer, handling, and use of living modified organisms (LMOs) resulting from modern biotechnology. Additionally, the World Health Organisation (WHO) provides guidelines and frameworks for biosecurity and biosafety in laboratories and biotechnology practices.

 

Nationally, various countries have implemented specific regulations and oversight mechanisms for biosecurity. In the United States, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) provide guidelines to secure biological materials and prevent their misuse.

 

The Federal Select Agent Program regulates the possession, use, and transfer of biological agents and toxins that pose significant threats to public, animal, or plant health. In Europe, the European Union enforces strict biosecurity regulations through the EU Dual-Use Regulation, which controls the export and transfer of pathogens and genetic materials.

Gaps and Challenges

Current regulatory frameworks for synthetic biology often struggle to keep pace with the rapid advancements in the field. One significant gap is the lack of international standardisation and coordination. While some countries have stringent regulations, others may have more lenient or outdated policies, creating inconsistencies that can be exploited. Moreover, the existing frameworks, such as the Biological Weapons Convention often lack enforcement mechanisms, making it difficult to ensure compliance across different jurisdictions.

 

Enforcement issues also arise from the challenge of monitoring and controlling dual-use technologies. Regulators may not have the necessary tools or expertise to effectively oversee the wide range of applications and potential misuses of synthetic biology. The fast-paced nature of scientific innovation means that regulations can quickly become obsolete, requiring continuous updates and revisions.

 

Despite significant progress, current biosecurity technologies face several limitations. Gene editing tools like CRISPR-Cas9, while powerful, are not foolproof. Off-target effects and unintended genetic changes remain a concern, potentially leading to harmful consequences. Furthermore, built-in safety mechanisms, such as anti-CRISPR proteins, are still in the developmental stages and may not yet be reliable for widespread use.

 

Another challenge is the detection and monitoring of synthetic organisms. Traditional biosecurity measures, such as physical containment, may not be sufficient for managing the risks associated with advanced synthetic biology. There is also a need for more sophisticated digital biosecurity tools that can track and analyse genetic data to prevent the synthesis of harmful organisms. However, these tools require significant investment and ongoing development to keep up with emerging threats.

Dr Jason Lee

 

The most significant biosecurity risks in the next decade could potentially involve the misuse of synthetic technology to either create or unintentionally release a deadly pathogen, which could cause the next pandemic.

 

This risk is compounded by the growing accessibility of synthetic biology tools that can be exploited for bioterrorism. The intentional misuse of biotechnologies to engineer pathogens with enhanced virulence or resistance to treatments poses a severe threat to global security. Implementing robust biosecurity measures is crucial to mitigate these risks and uphold safe scientific advancement.

 

 

Dr Lee Khai Wooi

School of Biosciences

Future Directions in Synthetic Biosecurity

The future of biosecurity in synthetic biology is being shaped by several emerging technologies and innovative approaches designed to enhance safety and mitigate risks.

 

One such approach is the integration of artificial intelligence (AI) in biosecurity. AI can be used to predict and identify potential biosecurity threats by analysing large datasets of genetic information. Machine learning algorithms can detect unusual patterns or sequences in DNA that may indicate the creation of harmful pathogens. Recent advancements in AI have led to the development of more sophisticated models capable of simulating biological processes and predicting the outcomes of genetic modifications, thus providing an additional layer of security in synthetic biology research.

Computational Biology

Advanced biosensors are another critical innovation in biosecurity. These devices can detect the presence of specific biological agents in the environment in real-time. For example, researchers have developed portable biosensors that can identify pathogenic bacteria and viruses with high sensitivity and specificity. These biosensors are essential for early detection and rapid response to biological threats, whether they are naturally occurring or the result of malicious intent.

 

Investment in biosecurity research and infrastructure, along with training programmes for scientists and researchers, will further bolster our ability to manage biosecurity threats. Engaging the public in informed discussions about the ethical and societal implications of synthetic biology is also crucial for gaining societal trust and support.

Conclusion

As we stand at the precipice of a new era defined by the unprecedented capabilities of synthetic biology, we are reminded of the words of renowned biologist E.O. Wilson: ‘The real problem of humanity is the following: we have paleolithic emotions, medieval institutions, and god-like technology.’ Prometheus gifted humanity with fire, a powerful tool that could nurture and destroy. Similarly, synthetic biology offers us tools with the potential to cure diseases, sustain our planet, and solve some of the most pressing challenges of our time. Yet, these same tools can unleash dangers if misused or left unchecked.

 

As we move forward, embracing the promise of synthetic biology while remaining vigilant about its perils, we can navigate the complexities of this new biological frontier. Together, through collaborative efforts and a steadfast commitment to biosecurity, we can ensure that the torch of synthetic biology illuminates a future of health, sustainability, and safety for all.

Ready to safeguard the future? Find out how our Biosciences programme and lead innovations in biosecurity and synthetic biology. Book an appointment with our education counsellors to learn how you can make a real impact.

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