From DNA to GMP: UK RNA service now fully open
For industry innovators who need to get their mRNA candidate into clinic at pace but are being held back by challenges in viable scaling and clinical trial manufacture…
…the UK’s RNA Centre of Excellence is now fully open to industry.
The Centre’s team of world-class process operators, development scientists, and Quality Professionals provides a high-readiness capability for companies that either aren’t up and running themselves or aren’t ready to be locked into long-term CDMO arrangements — that’s why the centre was set up and backed by the UK Government.
The RNA Centre of Excellence gives industry access to:
RNA-LNP process intensification expertise to maximise yield and efficiencies, upstream and downstream
GMP batch manufacturing for clinical trials, with tech transfer to you and your chosen commercial manufacturer
RNA Training Academy training programmes and consultancy for your staff, bespoke to your requirements
…all in one location, delivered by one connected team.
Optimising RNA-LNP processes
When it comes to moving an mRNA candidate into clinical trials, scaling lab processes into clinical trial supply can be frustratingly slow. Global organisations find that, although they have internal capability, connecting that know-how across international regions and getting the right priority status can be really time-consuming. And for start-ups and academic entrepreneurs, this part of the process may simply fall beyond existing infrastructure.
The scientists at the RNA Centre of Excellence are experts in optimising and intensifying RNA-LNP processes. They understand that, at this stage, innovators need processes that will scale up for clinic use and work in a commercial setting without having to be changed.
Download CPI’s Dr Philip Probert’s recent presentation on innovative intensification techniques for the sustainable scaling RNA-LNP candidates.
With the whole team working together under one roof and using your manufacturing technology of choice, they provide:
- Extensive RNA and LNP process development experience that can be applied to different formats, including RNA, saRNA and polycistronic platforms
- Access to a wide range of equipment – bench top or fully automated
- Translation of R&D to GMP clinical supply – in one location, by the same team…
GMP clinical supply
When it comes to moving RNA candidates into clinic as quickly as possible, establishing and connecting the supply chain can be challenging. Often the capabilities required exist in different geographic regions and the supply chain is disconnected. Managing an international supply chain takes up precious time – milestones start slipping away and the pace begins to be lost.
The GMP facility at the RNA Centre of Excellence is set up to enable industry to go from DNA to encapsulated bulk for in-human use in less than a month:
- Working with one team of scientists and quality professionals in one location
- Using the process of your choice
- Without being locked into a long-term commercial agreement.
The Centre can provide the tech transfer to your commercial manufacturing route of choice and train your staff along the way.
The RNA Training Academy
The clinical potential of mRNA vaccines and therapeutics is significant. But with innovation comes new processes and new processes require new skills — highly specialised skills that require hands-on training. But with an early-stage candidate, the internal priority will often be proving the science so allocating internal resource for training can be difficult.
The Training Academy at The RNA Centre of Excellence provides curated courses that are tailored to the organisation, specific to the science and delivered at the site of choice. The training can be combined with consultancy work as specific issues with the product or facility arise. For the individual delegates, all courses are CPD certified and endorsed by the Royal Society of Chemistry.
Let's innovate together
To investigate whether the facility is the right match for your circumstances, a team member can arrange an informal meeting to discuss the capabilities you need and the work we do. Fill in this short form or email Asif Tulah.
For more information
Let’s innovate together
To find out more about how we can work together, please enter your details below.