兰德-Developing-standards-to-support-the-synthetic-biology-value-chain_108页_3mb

Summary of "Developing standards to support the synthetic biology value chain"

Core Content

This report, commissioned by the British Standards Institution (BSI), provides an in-depth analysis of the synthetic biology value chain, identifying its current structure, the challenges and opportunities it faces, and the potential role of standards in supporting its future development. The study was conducted through a combination of rapid literature review and interviews with over 30 stakeholders, including companies, end-users, and public sector representatives.

Main Findings

The Synthetic Biology Value Chain

• The value chain is described as starting with an idea, followed by design, build, test, and finally scale-up.
• Each stage of the value chain involves various computational and physical inputs, often sourced from other companies in the chain.
• The value chain interacts with other sectors in two main ways: absorption (using synthetic biology components within another industry) and selling-in (designing a product through synthetic biology and selling it into another sector's production process).
• These interactions can enhance the value chain of other sectors through the integration of synthetic biology.

Barriers and Challenges

• Idea Stage: Limited scientific knowledge, reluctance of established companies to adopt synthetic biology, and poor communication between academia and industry.
• Design-Build-Test Stage: Poor information exchange, lack of equipment integration, and intellectual property (IP) issues.
• Scale-Up Stage: The most numerous challenges include reluctance to change, difficulty in maintaining revenue, regulatory hurdles, high investment requirements, public perception, environmental concerns, and IP rights.

Role of Standards

• Standards can reduce uncertainty and help overcome commercialisation barriers.
• They can improve communication, enable interoperability, and support innovation by fostering competition and setting clear expectations.
• Standards can also enhance regulatory efficiency, support reproducibility, and build public trust.
• Soft standards (e.g., norms and behaviors) are important in shaping the perception of synthetic biology and influencing its adoption.

Key Drivers (PESTLE Framework)

• Political: Uncertainty over future regulations and lack of international coordination.
• Economic: High investment costs and perceived risk make synthetic biology an unattractive proposition for many investors.
• Social: Public perception and social acceptability of synthetic biology products are crucial, influenced by the perceived balance between benefits and risks.
• Technological: Poor reproducibility of engineered organisms and lack of interoperability in R&D protocols hinder progress.
• Legal: Legal factors are viewed differently by companies and regulators.
• Environmental: Concerns about the potential impact of released organisms on biodiversity and human health.

Scenarios for Future Development

Four scenarios were developed to explore future opportunities and the role of standards:

1. Catastrophe leads to containment: A highly regulated, conservative environment.
2. Synthetic biology for the public good: Emphasis on products that serve societal needs.
3. Synthetic biology and the 'entrepreneurial state': Strong government investment to drive innovation.
4. Sharing economy model: A landscape dominated by many small, specialised companies.

These scenarios highlight the potential influence of standards on innovation and value chain configuration.

Recommendations

• BSI and other stakeholders should prioritise standard development across the value chain, especially at the scale-up stage, as it is where most challenges are concentrated.
• Standards should not only address technical aspects but also include 'soft' standards that shape norms and public perception.
• Standards should be designed to support both incremental and disruptive innovation, and to address public trust and environmental concerns.
• The role of public-private partnerships should be explored, as they can help overcome market and institutional failures.
• The report suggests that BSI should consider how standards intersect with other industrial ecosystems, particularly as synthetic biology is often an enabler for other sectors.

Current Initiatives and Actors

• The UK government has identified synthetic biology as one of the "eight great technologies of the future" and has invested heavily in it, including £72 million for six Synthetic Biology Research Centres (SBRCs).
• The Synthetic Biology Leadership Council (SBLC) serves as a strategic coordinating body, with a Governance Subgroup promoting open and adaptive governance.
• The UK's Synthetic Biology for Growth Programme and SynbiCITE Innovation and Knowledge Centre (IKC) are key initiatives supporting the sector.
• International collaborations, such as with the US, EU, China, and Singapore, are also important for the development of synthetic biology.

Conclusion

The report concludes that standards are a critical tool for advancing the synthetic biology sector. While they cannot solve all challenges, they can significantly reduce barriers to commercialisation, enhance innovation, and support the development of a more defined and accepted industry. The findings suggest that a collaborative and adaptive approach to standard setting, involving both public and private stakeholders, will be essential for the sector's future growth.