CPI has opened the UK Intracellular Drug Delivery Centre to wider industry access following a development phase that screened more than 4,000 formulations and supported over ten commercial and collaborative projects.
The centre provides a coordinated route for companies developing RNA medicines, delivery systems, and other advanced therapeutics to use specialist formulation, biological assessment, and translational facilities. Its work is intended to reduce the fragmented testing and repeated development that can delay promising candidates before clinical manufacture.
CPI leads the programme in partnership with Medicines Discovery Catapult, the University of Liverpool, the University of Strathclyde, and Imperial College London. The centre was established with £10 million from Innovate UK’s Transforming Medicines Manufacturing programme.
RNA treatments can instruct cells to produce a therapeutic protein, silence a harmful gene, or alter biological pathways that are difficult to address using conventional small molecules. Before the payload can perform that function, however, it must survive manufacture, storage, administration, and the biological barriers separating it from the target cell.
Because unprotected RNA is unstable and vulnerable to degradation, developers use lipid nanoparticles, polymers, conjugates, and other carriers to protect it and control its movement through the body. The delivery system often determines whether an otherwise promising molecule reaches the correct tissue in a therapeutically useful concentration.
Small changes in particle size, composition, surface properties, purity, or process conditions can alter distribution, cellular uptake, and immune response. Development therefore depends on analytical methods, formulation equipment, raw material control, and manufacturing scale as much as the biological activity of the RNA itself.
The centre combines formulation design with functional characterisation, biodistribution, immunocompatibility, and translational decision making. Companies can enter through a single access point rather than commissioning a succession of disconnected studies from separate laboratories.
During the pilot phase, participating organisations contributed to eight peer-reviewed publications and worked with the Medicines and Healthcare products Regulatory Agency on a regulatory quick-start guide. Opening the infrastructure more widely turns that research collaboration into an accessible national development capability.
Connected evidence can reduce late development changes
Drug delivery programmes frequently encounter difficulty through an accumulation of smaller uncertainties rather than one obvious defect. A formulation may perform well in an early laboratory test but become difficult to reproduce, unstable during storage, incompatible with filling equipment, or less effective after transfer into another biological model.
Generating connected evidence earlier allows weaker candidates to be removed before companies commit to expensive clinical material, dedicated equipment, or long toxicology programmes. Resources can then be concentrated on delivery systems with a clearer route to reproducible manufacture.
The centre’s distributed structure brings together expertise located across several institutions while maintaining a coordinated programme. Such an arrangement reflects the multidisciplinary character of RNA medicine, which combines molecular biology, chemical engineering, materials science, analytics, toxicology, regulation, and pharmaceutical production.
Manufacturing questions become increasingly difficult as a treatment advances. Mixing energy, order of addition, temperature, flow rate, concentration, filtration, and handling can alter the final delivery particle, while a process established at millilitre scale may behave differently when transferred to continuous equipment or a larger batch.
Analytical methods must distinguish between acceptable process variation and changes capable of affecting safety or performance. Developers need to identify which product attributes are critical, how accurately they can be measured, and whether the methods remain reliable when used for regulated manufacturing.
Advanced therapy producers are investing in more standardised production systems as programmes move beyond laboratory and early clinical work. The expansion of automated cell therapy capacity, including highly automated smart factory operations, reflects the same pressure to turn complex biological processes into repeatable industrial production.
RNA medicines involve different cells, materials, and unit operations, yet the commercial challenge is comparable. Scientific performance must be translated into a process that produces consistent material, controls contamination, satisfies regulators, and remains economical at the required volume.
Shared infrastructure can be especially valuable for smaller developers that cannot justify building dedicated formulation and analytical facilities before a candidate has generated sufficient evidence. It can also expose a programme to a wider concentration of specialist knowledge than one company could recruit internally.
Commercial transfer will still require careful planning. Work completed through the centre must ultimately move into a contract manufacturing organisation or dedicated production plant, where equipment, materials, staff, and quality systems may differ from those used during development.
Raw material supply presents another constraint because specialised lipids, polymers, reagents, and analytical standards may be available from a limited number of qualified producers. Formulations designed around materials without a secure or scalable supply route can face extensive redevelopment later.
Clinical efficacy, reimbursement, intellectual property, and investment conditions will continue to determine which programmes progress. The centre cannot remove those commercial risks, although stronger formulation and manufacturing evidence can prevent avoidable technical failures from consuming scarce development capital.
Its opening provides a national route through one of the field’s most persistent bottlenecks. Britain already has substantial research capability in RNA biology and advanced medicines; connecting that science with formulation, analytics, regulatory evidence, and scale-up gives more programmes the opportunity to progress towards clinical and commercial production.
