Synthetic biology bears the hallmarks of an industry finding its feet: heavy on R&D, flushed with seed funding and new companies springing up on a monthly basis. Synthetic biology is still in its infancy, and as it learns to take its first steps to fully integrate into the market, it must put its best foot forward to truly integrate biodesign for engineering biology.Last year, Cambridge Consultants brought together leaders in the field for a workshop on advancing synthetic biology. The key question they asked participants was: “What are the tools and technologies we need to develop in the next five years to make biodesign a commercially successful approach that drives significant business activity?”The result was Building the Business of Biodesign, a report detailing the major issues plaguing the field and, crucially, the workshopped strategies to help advance the field. Eighteen months on from publication, James Hallinan, Business Development Manager for Cambridge Consultants, updates us on some of the strategies outlined in the report.

The key components of the next five years: predictability, supply chain, and accessibility

The workshop challenged its participants to first think about where the industry should be in five years’ time. With a 2023 target set, the next steps were to identify the challenges and opportunities around key areas of interest. Finally, the participants were asked to assess how much progress could be made on these in the next five years. Three key challenges were identified in the workshop: predictability, supply chain, and accessibility.

Predictability

Biology is inherently unpredictable. In practice the tools and processes used are not sufficiently defined for standardized outputs. Predictability relies on, more than anything else, tons of high-quality data.The Biodesign report highlights data collection and data completeness as being essential to predictability. Third-party software that can interface with many different instruments would be highly beneficial, bringing data together. Automation of workflows provides the level of data completeness necessary for simulation of data. Data collection is improving constantly, but reliable, low-cost, real-time data acquisition is a must for developing simulations and testing predictability. Analysis poses another issue.Hallinan explains, “You need some way of analyzing, interpreting, and mining that data. The data sets are getting too big to be sensibly assessed by humans. Machine learning is really essential for being able to make sense of those enormous datasets, which are getting bigger as we move to scale-up.”Adoption of uniform tools in the field would also allow more engineering-based approaches to be used across the supply chain, leading to more standardized and predictable results. The skill sets required in biodesign also need standardization. Biologists adopting new skills such as coding and machine learning, as well as engineers learning biology, appears to be the way forward.In the last 18 months, companies such as Synthace, Opentrons, and Riffyn have released research design software capable of interacting with various equipment, planning experiments and analyzing data. These platforms, taken on by early adopters in the field of synthetic biology, will likely set the trend for user needs over the next few years.Academia has begun to adapt too. Biodesign and engineering biology courses in UK universities have been running for half a decade. The need to increase available studentships has been recognized as recently as last year when the UK research councils awarded funding for a dedicated post-doctoral school at Imperial College, London.

Supply chain and scale up

The report uses the car as an example of an effective supply chain. Different manufacturers make different parts of the car, but they’re all assembled and integrated without issue despite originating separately. Such is the level of standardization and specialization required for the biodesign industry. For synthetic biology to become a competitive biodesign industry, it must compete with already established supply chains that already enjoy commercial confidence. Chemical rather than biological approaches are the gold standard. In order to compete, biodesign must demonstrate improved specialization, standardization, scalability and downstream processing (DSP).This is a multi-tiered challenge, Hallinan explains, “There is a skills gap… in terms of having knowledge of things like new product introduction and dealing with distribution chains. There’s the challenge of commercial scalability at one end, the challenge of manufacturing scalability in the middle and the challenge of how is your product processed and finished.”Currently, larger synthetic biology companies are making all components and assembling the product themselves. Smaller companies, which do not have such resources, are at a loss. An idea is that contract manufacturing organizations (CMOs) may contribute to producing specialized components. This challenges synthetic biology companies to become more accessible to CMOs, and vice versa. A key issue is taking DSP into consideration during R&D.Hallinan adds, “People are introducing more variables into what performance their product needs to have when they're doing R&D. These variables are things like ease of processing, appropriateness and applicability to what their end-users need, making their product in a what which will fit with other elements of the workflow that their end customers have.”Scale-up has not yet materialized for synthetic biology outside of the larger companies who can do so in-house. There is a clear market gap for CMOs that can manufacture a range of products in a single facility. Start-up synthetic biology companies don’t have the capital to establish their own large-scale production facility. In the past year, the CPI in the UK has made a large push to help smaller companies in this area and the conversation has now shifted from encouraging foundation of new start-ups to encouraging them to scale up.

Accessibility

Like any emerging field, synthetic biology is dogged by a lack of understanding on several levels. Similarly, accessibility within the field and communication within the community is key to improving accessibility. It is, however, one of the most collaborative research communities out there.“In established industries, the top tier companies selling that product don’t make that product. They perhaps assemble that product, but they’re not manufacturing all the way. Whereas in the synbio space, you have a lot of companies vertically integrated – trying to make all of the components, assemble it, package it and sell it. Having this does not fit well with scalability,” Hallinan notes.This observation has seen companies move towards collaborations with one another, allowing companies to scale in a more effective way than going it alone. As software platforms and automated systems become more widely adopted, standardization in the field will spread through these collaborations into a more integrated field and, eventually, industrial biodesign.Despite political turbulence and the infancy of the field, synthetic biology is still seeing a great degree of investment in the UK. Cambridge Consultants are advising their synthetic biology clients on the best ways to address these issues and more outlined in their broad report to build towards the future the field wants to achieve.Hallinan wholeheartedly believes that “Investing in a knowledge economy is important and the UK has long been a leader in life sciences, such as the emerging field of synthetic biology. We are in a good position and it’s important that position is maintained and enhanced as we go forward.”