Accelerating innovation in RNA therapeutics
Develop, optimise and scale-up novel RNA therapies and vaccines
Supporting the next generation of biologic products and manufacturing processes
We’re a leading independent technology innovation centre and a founding member of the UK’s High Value Manufacturing Catapult. As an RNA Centre of Excellence, we use our expertise to accelerate the development, scale-up and manufacture of novel RNA therapies and vaccines.
Operating in both an R&D and GMP environment, we build cross-functional teams tailored to your needs, providing you with the most suitable support, facilities and guidance for you and your innovation.
Opportunities in RNA
The use of RNA as a therapeutic and as a potential vaccine platform has shown promise for many years, both via short-chain oligonucleotides and longer chain mRNA and self-amplifying RNA. Following the rapid development, clinical trials and approval of highly effective mRNA-based vaccines during the COVID-19 pandemic, there is significant potential to develop and improve manufacturing approaches to meet the future demand for this exciting emerging technology.
Our RNA therapeutics capabilities
Our end-to-end process for RNA development and scale-up is the only UK based company currently capable of developing, manufacturing and encapsulating RNA vaccines ready for use in clinical trials in one location.
Our expert knowledge and state-of-the-art GMP capabilities to support your project:
Assistance in plasmid vector design for transient and stable applications
Creation of GMP compliant DNA from plasmid and other sources, master and research cell banks. For viral applications, can also carry out viral seed banking
Enzymic synthesis of mRNA, capping of mRNA and purification of RNA product
Capabilities and platform processes for downstream purification, using filtration or chromatographic approaches
Process development and state-of-the-art equipment for scale-up of nanotherapeutic based systems, such as lipid nanoparticle encapsulated RNA, including choice of manufacturing process, development and scale-up of purification strategies, formulation with cryoprotectants for successful lyophilisation via freeze-drying and product characterisation
Product and titre optimisation using a design of experiment (DOE) approach, utilising our ambr15 and ambr250 automated bioreactor systems
Ability to produce quantities of RNA products (material generation) using a CPI standard or customer defined process
Process characterisation analytics, purity/identity/concentration,residual/host-cell protein and endotoxin assessments.
Our track record of innovation
We have worked on a number of RNA projects with multiple partners ranging from SMEs to larger corporates and academic institutions.
- Our expertise in RNA vaccine development has been employed in the mRNA workstream of the UK Government’s Vaccine Taskforce as part of the national drive to identify and produce effective vaccines for COVID-19. Working with Imperial College London and using our biologics and formulation capabilities, we have developed steps to enable scale-up to 4L synthesis of a saRNA and lipid nanoparticle encapsulation process, achieving the largest scale saRNA vaccine manufacture in the UK.
- We’re supporting the development of an mRNA ‘vaccine library’ as part of the UK Government’s vaccine support package. The vaccine library will form the basis of a rapid response facility, which will enable mRNA vaccines to be developed to help protect against new variants of COVID-19, as and when they emerge.
- We recently launched a project at the Medicines Manufacturing Innovation Centre aiming to revolutionise the manufacture of oligonucleotides, short strands of synthetic DNA or RNA. This collaborative project between industry and government aims to develop a scalable, sustainable and more cost-effective medicines manufacturing process.
Our core capabilities
As an independent facility, we have no alignment to proprietary technologies or contract manufacturing lock-ins – meaning processes that we develop with you can be transferred to your manufacturing site or CDMO of your choosing. Our research and development work is ISO9001 certified and we manufacture under GMP standards.
Access to bioprocess development and scale-up experts.
From small-scale to large-scale manufacturing.
To a client’s manufacturing facility or CDMO.
Expertise in formulation
Cryopreservation development, forced degradation and stability studies.
Experience in helping companies to develop an optimised protocol for the production of their nucleic acid-based process, reduce batch-batch variability and improve product quality and quantity.
Read what our experts have to say about vaccine development