The project aims to evaluate a new microfluidic-based platform for the scale-up, process development and manufacture of nanoformulated medicines. If successful, CPI will make the new microfluidic-based platform available on an open-access basis at its National Formulation Centre. This will aid the development of new products and technologies, emerging from academia and the biotech sector, for clinical evaluation and commercialisation.
Nanoformulations can enhance conventional drug properties, such as improving intracellular delivery and tissue targeting. Ensuring that the right amount of a molecule can be delivered to the right tissue at the right time can enhance health outcomes and reduce negative side effects. Nanoformulations can therefore provide medicines and vaccines that are more effective, and enable new therapies for difficult-to-target sites, such as the delivery of nucleic acid therapies for cancer treatment.
The market for nanoformulated medicines is growing at a significant rate, with an estimated market value of $15.8 billion in 2014 and forecasted growth to $44.5 billion by 2019. However, the development of robust and scalable processes for nanomedicines manufacture remains a challenge, with poor manufacturability being a potential barrier to commercial success for the next generation of nanoformulated medicines. The outcomes of the project have the potential to confer significant benefits for future medicines development, whilst further strengthening the North East of England’s position as a hub for medicines manufacture.
As part of this project, CPI will collaborate closely with a range of organisations including the University of Manchester, the University of Strathclyde, AstraZeneca, Pfizer, Croda, Malvern PANalytical, and Precision Nanosystems. These partners will contribute knowledge and expertise relating to the design, development and manufacture of nanomedicines. The manufacturing platform for this project will exploit microfluidic devices in which the mixing of reagents can be exquisitely controlled. This will deliver structures that allow the development of nanoformulated medicines with highly controlled properties. Use of the selected manufacturing platform technology therefore has the potential to deliver better products and processes, whilst reducing the time taken to develop new nanoformulations for use in the clinical development of investigational medicines.
“We are thrilled to be working with such a strong consortium of collaborators on a project that will have positive impact for a rapidly emerging market,” says Graeme Cruickshank, Director of CPI’s National Formulation Centre. “The development of this microfluidics platform will underpin our capability to enable companies to robustly scale up novel nanoformulations, improving the chances of a positive result in pre-clinical trials. Ultimately this will lead to benefits for large and small companies alike.”
Yvonne Perrie, Professor in drug delivery at the University of Strathclyde says “Having worked in the field of liposomes and microfluidics for some time now, we are delighted to be part of this project and add in our experience in developing scalable manufacturing processes for liposomes and nanomedicines.”