Oligonucleotide manufacturing centre to open in Scotland

Credit: Centre for Process Innnovation (CPI)

Following the UK government’s recent announcement of a £520 million funding boost for UK manufacturing, a new Oligonucleotide Manufacturing Innovation Centre of Excellence in Scotland will develop innovative and sustainable techniques for these medicines.

According to the Centre for Process Innovation (CPI), oligonucleotides therapeutics use short, chemically synthesised fragments of DNA or RNA to modulate protein expression and ultimately treat the underlying cause of disease. Importantly, these novel therapeutics have potential to revolutionise the treatment of ‘untreatable’ conditions.

UK partnership set to revolutionise oligonucleotide manufacture

Supporting demand for oligonucleotide medicines

Current capacity for manufacturing oligonucleotides “is insufficient” CPI stated. “There is a massive gap in the supply and demand for this innovative technology. We want to change that and allow businesses to use this new facility so they can go and produce the medicines people need,” Dave Tudor, Director of Pharmaceuticals at CPI commented.  For example, CPI asserted that lead times for clinical trial materials are hindering new therapies being developed.

A new innovation hub in Scotland’s manufacturing landscape

To help address these challenges, the new centre will help to “drive innovation and support clinical manufacture.”

Speaking to EPR, Tudor explained that the site “will provide a collaborative GMP-capable space to enable current and next generation manufacturing technologies to be demonstrated within the same facility.

“… this unique capability will enable companies to compare innovative manufacturing technologies, such as membrane and biocatalytic technologies, against the standard solid state phosphoramidite manufacturing method.

“Currently, the sustainability profile of oligonucleotide manufacturing is a significant risk to the potential future of these therapies and with future drugs being targeted at larger patient populations, without resolving these challenges, delivering cost effective and sustainable solutions for these life-changing therapies to patients is put at risk.”

On the UK government’s funding announcement, Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry (ABPI) commented: “This package of support will help boost our sector’s investment in UK-based research and manufacturing… [and] is a major step forward in delivering on our shared ambitions for long-term growth.”

The new facility will put Scotland “at the heart of advanced medicine manufacturing techniques… By placing this centre alongside our Medicines Manufacturing Innovation Centre, we can benefit from our existing skills in oligonucleotide manufacturing to combat those challenges while bringing inward investment to the region,” Tudor added.

The Oligonucleotide Manufacturing Innovation Centre of Excellence will also facilitate “a highly skilled workforce” to be trained and development to accelerate access of these medicines to patients, CPI noted.

The new facility focusing on oligonucleotides will be CPI’s second facility within the Advanced Manufacturing Innovation District Scotland (AMIDS), its Medicines Manufacturing Innovation Centre (MMIC). This is a first-of-its-kind collaboration for the pharma industry. Partners include AstraZeneca, GSK, and the University of Strathclyde.

CPI confirmed that the centre will establish operations during 2024 and be finished in late 2025.

The project will be jointly funded by the UK and Scottish Governments. It will utilise £20 million to support construction & kit-out the facility, CPI stated on X.