Delivering medicines at a nanoscale.
The scaling-up challenge for nanomedicines
Nanomedicines are complex medicines that leverage nanotechnology. They ensure the right active ingredient reaches the right drug target at the right time, leading to fewer potential side effects.
Nanomedicines enable the intracellular delivery of therapeutics at both the cellular and genetic level. They can pass through multiple membrane types, including cell membranes, blood vessel junctions, and the blood–brain barrier, to interact with only specific target sites or cells in the body, treating disease and reducing side effects.
Nanomedicines were thrust into the limelight during COVID-19, with both the Pfizer/BioNTech and Moderna vaccines using lipid nanoparticle (LNP) encapsulated mRNA to enable the body's own cells to produce and present the SARS-CoV-2 spike protein on their surface to initiate an immune response.
The rapid development and deployment of these vaccines demonstrates the untapped potential of nanomedicines to revolutionise the way we treat and prevent disease.
What's challenging about commercialising nanomedicine innovations?
Small molecules and biologics comprise many of today’s drugs, but we’re witnessing an increasing trend towards more complex medicines, like RNA, messenger RNA (mRNA), small activating RNA (saRNA), small interfering RNA (siRNA) and DNA-based therapies.
However, getting these active ingredients to their target within the body is a challenge as they are very susceptible to degradation. Further, they need to be delivered across cell membranes to enact their therapeutic benefit. Such challenges can be addressed through the use of nanotherapeutic delivery systems, where the active ingredient is encapsulated in a delivery vehicle, including polymeric nanoparticles, liposomes or LNPs.
Additionally, the development of robust and scalable processes for nanomedicines remains a challenge. Precise control of a product’s critical quality attributes (CQAs), such as particle size, surface properties, and microstructure, is required during manufacture to deliver the required biological performance.
How is CPI enabling nanomedicine solutions?
We have the expertise and equipment to support the development of manufacturing processes for a broad range of innovative nanomedicines. Combining technical know-how with our state-of-the-art manufacturing technologies, we support the manufacture of novel nanomedicine candidates at scale.
As well as designing for scale-up, we can support the development of purification strategies in both batch and continuous manufacturing modes. We can also extend the shelf-life of nanomedicines through formulation optimisation with cryoprotectants to ensure product stability when freeze-drying. All this is underpinned by our physicochemical expertise, meaning we are skilled in characterising the particle size, particle charge, encapsulation efficiency, composition and release rate, of nanomedicines.
Our position at the centre of the UK’s academic, industry and government networks mean we have the influence to support the rapid development of new nanotherapeutics and help prepare products for the regulatory processes necessary for early phase trials and commercialisation.
CPI's nanomedicine capabilities
Our expertise and facilities can support the development of scalable and robust nanomedicine manufacture.
Process development for the scale-up of nanoparticulate-based systems
Development and scale-up of purification strategies
Optimisation of formulations for stability
Digital tools and technologies
Process engineering expertise
GMP-compliant manufacturing facilities
State-of-the-art technologies, including micro-mixing, impinging jet, and microfluidics
Business Development Lead, CPI
CPI has skillsets and equipment that are not readily available anywhere else. By using CPI's skills, we have saved many months of process development.
Dr Jill Makin
Chief Technology Officer, Touchlight Genetics
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Thanks to the expertise in drug development and manufacture brought by the colleagues from Quay, CPI and Pharmidex, we successfully developed a scalable manufacturing process for oral antibody products.
Formulation Scientist, Intract Pharma
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