Turning the UK into mRNA superpower – how do we get to the top table?

Throughout history, the capability to manufacture strategically important resources has been core to a country’s economic success. Steel, cement and semiconductors have all helped build the modern world.

But a new wave of progress is forming, with biomanufacturing and messenger RNA (mRNA) at its forefront. For the UK, embracing the transformative potential of these technologies will be critical to its future.

The breakthroughs in mRNA are among the great scientific and technological developments of recent times. It is capable of powering innovative vaccines and therapeutics for an array of diseases and creating breakthroughs for previously incurable conditions, including cancers and rare diseases.

New vaccines can be rapidly designed, quickly adapted to address specific viruses, and manufactured at scale – nearly seven billion mRNA vaccines were made for COVID-19 last year alone. Together, it makes the technology a vital public health and biosecurity tool, as well as a driver of economic opportunity.

The UK has already begun to develop its capabilities in this area. The country had successes in accelerating COVID-19 vaccines. It was the first in the world to administer the Pfizer-BioNtech vaccine outside a clinical trial, while Oxford University helped develop our own domestic vaccine with AstraZeneca.

It has also signed strategic partnerships with Moderna and BioNTech, global leaders in this technology. These promise to provide personalised treatment to about 10,000 patients by 2030.

But we have a track record of not capitalising on early wins. Despite pioneering the development of monoclonal antibodies and foundational work for the world’s top-selling and first $20 billion drug, Humira, the UK failed to capture this commercial potential, which largely unfolded in the United States. This cannot happen with mRNA.

Biotech is increasingly competitive and building our strength in this industry requires much more than strength in basic science.

The starting point is investing in an innovation ecosystem around mRNA, which should be disease agnostic, but tightly interweave mRNA design, production, testing and deployment capabilities. All of this requires a strong digital and data-driven infrastructure to help drive progress.

The UK could drive home an advantage here, for example by using genomics and Biobank data infrastructure to help with the design of new mRNA therapeutics. For testing, this data can then be connected with clinical-trial management systems, while the NHS App can also facilitate enrolment and retention in clinical trials.

This requires reforms to strengthen clinical trial infrastructure, including increasing research capacity, accelerating data infrastructure and supporting decentralised trials. Public procurement through the NHS – the UK’s main domestic market – also has a huge role to play.

The systems must be configured and incentivised to do so, and trial and redesign new care pathways so that they are ready to adopt and roll out mRNA technology.

For manufacturing, production capacity should be built to enable both clinical trials and subsequent large-scale or commercial deployment. This will require a two-pronged strategy that is agile in small-batch production and robust in high-volume production. Firms can pursue this separately, or in combination.

First is small-scale manufacturing to improve the availability of bespoke, clinical-grade mRNA for clinical trials to spur innovation, and the production of personalised mRNA medicines for diseases such as cancer.

A foundry model with distributed, multi-product, mRNA manufacturing capabilities is necessary for this. Companies can specialise in different parts of the value chain.
Some may be dedicated to fabrication, which includes the manufacturing, synthesis and purification of desired mRNA sequences, and encapsulating them into delivery vehicles (such as lipid nano-particles) that can help deliver the mRNA into cells and prevent its degradation.

Others may become ‘fabless’ and focus only on designing the mRNA sequences for drug products, without their own manufacturing facilities. This development could encourage a diverse playing field that offers competitive value propositions, driving quality up, and costs down.

Second is large-scale mRNA manufacturing capacity that benefits from economies of scale, and is independent from the risk profiles associated with biopharmaceutical companies.

Partnerships with biopharmaceutical companies will be vital to the initial ramp-up, but over-reliance could limit future manufacturing flexibility. The country therefore needs to nurture its own dedicated mRNA manufacturing industry, and explore the ample opportunities for radically different mRNA manufacturing approaches and other technological innovations.

Ultimately, this will remove current mRNA production bottlenecks, improve the quality of the mRNA produced, reduce its costs, enable rapid large-scale manufacturing – and enable whole new classes of mRNA applications in areas such as gene therapy.

The country should also be clear that it is nearly impossible to have a complete, end-to-end supply chain within its borders. As the UK fortifies its existing strengths (e.g. manufacturing of lipid nanoparticles) and establishes capabilities for manufacturing drug substances, it needs to create a regional supply chain for fill-and-finish processes.

This involves a geographical extension beyond the ‘Golden Triangle’ – London, Oxford and Cambridge – towards more cost-effective regions within the UK, and in other countries in the European Union and NATO, where qualified specialist workforces can be employed at much lower cost, such as Slovakia, Poland or the Czech Republic.

The UK’s ambition to become an mRNA superpower is bold, but it is attainable. Good policy is necessary to drive this.

By doing so, the UK can harness the potential of mRNA technology to play a global leading role and be a driving force of the bio-industrial revolution to create innovation-led growth that can address some of the most pressing health and security challenges of the 21st Century. 

Henry Li is from the Tony Blair Institute. Go to institute.global
Miroslav Gasparek is CEO at Sensible Biotechnologies. Go to sensible.bio