UK collaboration will revolutionise oligonucleotide manufacturing

Screenshot from animation about oligonucleotides

The Medicines Manufacturing Innovation Centre (MMIC) has today launched a scalable, sustainable and more cost-effective way to make oligonucleotides.

Oligonucleotides are short strands of synthetic DNA or RNA that can be used to tackle both rare and more common diseases. They work by interfering with how genes are expressed.

This next generation therapeutic is now being explored to treat chronic diseases, like some types of heart disease, that affect large numbers of people. However, their usefulness is currently limited by inefficiencies, inherent in the existing manufacturing process.

With many prospective oligonucleotide-based medicines either in development or clinical trials, a cost-effective, sustainable manufacturing method will ensure current and future needs are met.

Pioneering production process

That’s why UK Research and Innovation (UKRI) is investing £1m into the collaboration alongside:

  • AstraZeneca
  • Exactmer
  • Novartis.

This funding will help the UK become the first country in the world to deliver this pioneering production process at a large scale.

The collaboration will enable the partners to utilise their combined expertise across scale-up, analytics and process development with the goal of transforming the oligonucleotide supply chain.

Known as ‘Grand Challenge 3’, the project is one of a series of ‘Grand Challenges’, designed to tackle industrial hurdles currently limiting pharmaceutical manufacturing. The challenges are being explored in the MMIC, funded through the UKRI medicines manufacturing challenge.

The first medicine

Inclisiran, a small interfering RNA used in the treatment of atherosclerotic cardiovascular disease (ASCVD), will be the first medicine produced at scale as a result of this collaboration.

Initial production will take place at Exactmer’s facilities in Dagenham, with the large-scale later phases taking place at MMIC in Scotland.

The project is expected to span three years, with the final output being the demonstration of the commercial feasibility of manufacturing large scale oligonucleotide batches using improved methods.

Life sciences sector is thriving

Nadhim Zahawi, Minister for Life Sciences said:

The UK’s life sciences sector is thriving, and we’ve seen this first-hand over the past year as we’ve tackled coronavirus – from identifying crucial medicines and treatments to developing potentially lifesaving vaccines.

As we build back better, this pioneering collaboration between industry and government will help to scale up the UK manufacture of this new class of medicines so that we can roll out crucial therapeutics to treat people with chronic diseases and help save lives.

Life science’s champion, Professor Sir John Bell said:

The technical challenges that this collaboration is setting out to address will, if met, be transformative. The ability to produce next-generation oligonucleotide based-medicines at scale creates enormous potential to treat a wide range of common diseases, as well as cardiovascular disease where Inclisiran clearly has a role.

I am delighted to see this historic collaboration of industry and government launch here in the UK.

Sarah Goulding, joint medicines manufacturing challenge director at UKRI, said:

Oligonucleotides, are short strands of modified RNA or DNA that have wide ranging applications in advanced medicines, from genetic testing to life-saving treatments. To date, their therapeutic use has been limited to diseases impacting small numbers of patients.

Recent developments, however, have now shown them to be effective in treating chronic illnesses that impact large numbers of people.

Currently they’re expensive and time-consuming to produce, so we’re funding this project because it will develop technologies that enable oligonucleotides to be developed at an industrial scale, at speed and at lower cost, allowing this important development to help tackle today’s health challenges and those of the future.

Further information

About the Medicines Manufacturing Innovation Centre

The MMIC was established by a collaboration between:

  • UKRI
  • CPI
  • the University of Strathclyde
  • Scottish Enterprise and industry partners
  • AstraZeneca
  • GSK.

It will develop the medicines manufacturing processes of the future, enabling a more agile, responsive medicines supply chain through improved manufacturing processes.

It will enable new and disruptive technologies to be proven and allow the rapid adoption of next-generation processes that:

  • reduce risk
  • cut costs
  • save time

This helps to enable a healthier society and a robust UK economy.

About the medicines manufacturing challenge

This project has been funded by the medicines manufacturing challenge, part of the Industrial Strategy Challenge Fund (ISCF), delivered by UKRI.

Through the medicines manufacturing challenge, more than £180 million will be invested in infrastructure and projects that focus on accelerating the development and manufacture of new medicines and treatments, including vaccines.

Like other ISCF challenges, it brings together the UK’s world-leading research with business to meet the major industrial and societal challenges of our time.

It provides funding and support to UK businesses and researchers, part of the government’s £4.7 billion increase in research and development over the next four years and plays a central role in the government’s modern industrial strategy.

UKRI brings together the UK Research Councils, Innovate UK and Research England into a single organisation to create the best environment for research and innovation to flourish. The vision is to ensure the UK maintains its world- leading position in research and innovation. For more information visit the UKRI homepage.

 

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