Sarah R. Carter, Ph.D., Principal, Science Policy Consulting LLC Diane DiEuliis, Ph.D., Senior Research Fellow, National Defense University
https://wmdcenter.ndu.edu/Portals/97/SynBio-Industry-and-Biosecurity-Nov-201912.pdf
To better understand these biosecurity issues, we undertook a project to map the synthetic biology industry, including its products and customers. We also explored current business practices within the industry and began a multi-stakeholder discussion of how these practices can be developed to mitigate the potential for misuse and to protect capabilities. This project includes input from over 50 individuals, gathered through interviews, discussions during the workshop, and, in some cases, less formal conversations. […] We spoke to 37 industry representatives from companies actively engaged in developing synthetic biology tools and capabilities, venture capitalists, and non-profit entities that substantially contribute to the industry landscape. […] we spoke to 19 policy experts and government representatives.
[…] The industry is best described as an ecosystem of companies that are diverse, interconnected, and interdependent
Issues
The need for skilled and talented workers, particularly those capable of integrating multiple types of tools, was cited as an ongoing challenge. Scale-up of products to commercial scale is a critical step in every sector, from production of gene therapy vectors to microbial fermentation to crop planting. In addition to technical hurdles (e.g., ensuring that a microbe behaves similarly in a bioreactor as it does on the benchtop and engineering the end-to-end process), geographical challenges were often cited, including the need to move benchtop innovations from research labs in dense cities to areas where larger facilities can be built, that are nearer to feedstocks, or where seeds can be planted.
These incubators highlight the fact that many new synthetic biology companies can establish proof-of-principle for their innovations with small amounts of funding, in contrast to more traditional biotechnologies (Friedman 2019b).
Biosecurity, Misuse, and Vulnerabilities
- Access to Tools and Capabilities
- The Digitization of Biology
- Synthetic biology companies are generally very well aware of cybersecurity threats, and often use secure computational resources for databases, software, and other key intellectual property. However, the interconnected nature of the industry ecosystem creates challenges as those resources need to be shared or integrated into the operations or products of other companies, sometimes as part of complex supply chains. Protection of data is even more challenging as the synthetic biology industry becomes increasingly international.
- Data security risks
- hacked laboratory robotics that synthesize toxin DNA or tamper with microbial fermentation,
- sensors that fail to indicate pathogens or other contamination, and
- databases with substituted or corrupted DNA sequences.
- Benchtop DNA synthesis or genome editing machines could be hacked to bypass biosecurity or oversight measures.
- For companies that develop personalized medicines or cell therapies, these cyberbiosecurity risks may include direct harm to human health or risks to patient privacy.
- Synthetic Biology as an International Enterprise
- Customer screening for customers in other countries can be particularly difficult. In some areas of the world, oversight and physical security are lacking, leading to the potential for stolen organisms (along with IP) and other technologies. Data security is also more challenging in these contexts
- IP/Data ownership
- Best practices
- Customer screening
- how a product will be used or misused depends on the intent of the customer, which can be difficult or impossible to discern; these interactions depend on qualitative determinations of trustworthiness
- Determination of Potential Risks
- Data Security and Intellectual Property
- foreign investment
- ill fitted IP protection
- interconnection business (=>secured API)
- Customer screening