Why the global bioeconomy urgently needs technical standards and metrics

The global bioeconomy is estimated to be worth about $4 trillion, and more than 50 nations now have published bioeconomy strategies or have policies steering towards a sustainable bioeconomy. With the development of new technologies in engineering and synthetic biology, the bioeconomy is growing rapidly.

Growth of the sector will bring increased commercialization, scale-up and distributed manufacturing, and promote manufacturing resilience by diversifying production streams beyond traditional chemical manufacturing.

However, the current lack of standards and metrics that apply directly to such a large global industry could result in chaos, with failed interoperability and an inability to share data or allow for technology transfer internationally.

The International Organization for Standardization (ISO) has published only 35 standards directly related to biotechnology; in comparison, there are 79 published standards relating specifically to dental instruments.

As such, there is a call from industry representatives and academics alike to develop technical standards and metrics that can be applied across the innovation pipeline to support the growth of the bioeconomy.

The newly-published Engineering Biology Metrics and Technical Standards for the Global Bioeconomy report summarizes the findings of an international effort, bringing together stakeholders from across the world at regional workshops to discuss the needs and priorities for standardization within each region.

Coordinated by Imperial College London, the Engineering Biology Research Consortium (EBRC), the National Institute of Standards and Technology (NIST) and the National University of Singapore (NUS), and supported by Schmidt Sciences, the report addresses the sectors need for standards and metrics and the current lack of clarity on which standards to prioritize.

Ten key areas are identified, from standards on data format and data sharing, to standards and metrics applied to the scale-up process and establishing a standardized lexicon. These key areas present vital opportunities for targeted initiatives to address standardization needs across the field of synthetic biology.

Without standards and metrics, there will be missed opportunities for innovation and increased challenges across the innovation pipeline.

The sector risks becoming monopolized by a small number of large industry players as the barriers – including costs and regulatory hurdles – to getting new bio-made products to market are too high for small and medium-sized enterprises (SMEs).

Introducing standards and metrics that will support SMEs to scale-up will enable continued innovation and boost the bioeconomy.

The global bioeconomy has the potential to develop solutions to some of the world’s biggest challenges, from climate change to food security. Bioengineered products and processes can contribute towards a more sustainable future; however, this potential is not always clearly communicated. Applying standards can be an effective way to allow consumers to compare bioengineered products with non-bioengineered products.

To grow globally and contribute in a significant way to global challenges, standards and metrics are necessary to develop a shared understanding and enable knowledge transfer, data sharing and support distributed manufacturing and trade around the world.

Sustainability assessments are often used as a way to compare products, providing evidence of sustainability criteria met. A good example of this is the Life Cycle Assessment (LCA), which is already widely used.

However, the interpretation and application of such assessments can vary greatly, with no sector-specific considerations that could augment existing LCA standards and frameworks.

The published report calls for a standard LCA for engineering biology products, that could include origin and renewability of feedstocks, impacts of feedstock transportation, biodiversity impacts, and carbon intensity (e.g., for biocontainment facilities).

To accelerate the development of new products from biomass feedstocks, stakeholders called for more information about feedstock make-up, noting that manufacturers will always favour well-characterized starting material.

In response to such calls, a number of tools are also identified in the report to support standards, for example developing feedstock specification sheets, enabling researchers and industry to select appropriate feedstocks based on a set of pre-defined characteristics.

Stakeholders from across the Americas, Europe, Asia and Australia convened to discuss regional priorities for standardization across engineering biology.

Discussions highlighted the need to address even the most basic of concepts, such as defining what is meant by the term ‘bioeconomy’, or the sometimes-interchangeable use of the terms ‘engineering biology’ and ‘synthetic biology’.

Priority areas for standards differed across regions, partly reflecting diverse levels of technology readiness, or existing regulatory frameworks.

When considering standards and metrics that might be applied internationally, it is necessary to acknowledge such global differences in the current state of the bioeconomy, applications of synthetic biology and biotechnology, and public perceptions of bioengineered products and processes.

The published report identifies 10 key areas that represent priority pain points across the sector, which could be overcome or, at the least, minimized by applying relevant standards and metrics. The differing regional contexts and perspectives reflect the varying needs and priorities across the global bioeconomy.

However, these differences present opportunities to develop standards that apply to specific regions; to leverage regional strengths and ensure that standards are implemented sooner rather than later, and are appropriate to the regional context.

In parallel, it is important to pursue global coordination and harmonization in setting standards for the global bioeconomy. Where some regions are farther ahead in terms of technology readiness, or have more established practices already in place, there are opportunities to introduce standards that can then be adopted in time elsewhere.

Establishing standards and metrics for synthetic biology that can be applied to help advance the global bioeconomy will require input from stakeholders in government, academia and industry, as well as coordination with standards-setting bodies.

Crucially, funding programmes will be required to support such efforts, and further international collaboration will be key to ensure the successful application of standardization across the bioeconomy sector.

Juliette Malley, Project Manager, Task Force on Engineering Biology Metrics and Technical Standards for the Global Bioeconomy at Imperial College London, also contributed to this article.