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
We are the only UK based company currently capable of developing, manufacturing and encapsulating messenger and self-amplifying RNA vaccines and therapies ready for use in clinical trials in one location, through our end-to-end process for RNA development and scale-up.
Our expert knowledge and state-of-the-art GMP capabilities to support your project:
Assistance in the design of mRNA constructs including screening services
Synthesis, cloning and scale-up of DNA plasmid template suitable for in-vitro transcription of mRNA, including template linearisation with appropriate restriction enzyme(s)
Enzymatic synthesis of natural or modified (including Ψ and m1Ψ substituted) mRNA using enzymatic or co-transcriptional capping technology, with capability and platform processes for mRNA purification using filtration or chromatographic approaches
Quality and titre optimisation using a design of experiment (DOE) (supported with process modelling) approach at small scale (ul/ml) for cost-effective optimisation, with ability to linearly scale up to L scale in rocked bag bioreactor or stirred-tank reactor, and with the option for intermediate scale-up in ambr15 and ambr250 automated bioreactor systems
Process development and state-of-the-art equipment for scale-up of nanotherapeutic based delivery systems, such as lipid nanoparticle encapsulated RNA, including choice of manufacturing process, development and scale-up of purification strategies to match mRNA synthesis scale
Formulation development of encapsulated mRNA with cryoprotectants for successful lyophilisation via freeze-drying, including stability assessment and product characterisation
Execution of large scale processes for the supply of encapsulated material for pre-clinical or clinical studies using CPI platform or customer supplied process.
Established analytical methods for characterisation of product pre and post encapsulation, including concentration, purity,identity, residual impurities, particle sizing, zeta potential and encapsulation efficiency.
Development of bespoke analytical methods to support cell-based expression analysis of the translated product (pre and post encapsulation) including ELISA, western blotting and/or flow cytometry.
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