The problem
There are approximately 1 billion people living with a neglected tropical disease worldwide. Two of the main infectious diseases, visceral leishmaniasis and cryptococcal meningitis, account for 220,000 global deaths annually – most of these fatalities are children.
These diseases can be treated with liposomal amphotericin B nanomedicine (which measures ~100 nm), a safer and more efficacious version of amphotericin B. However, due to the difficulties and costs associated with large scale production, there is a significant global supply shortage of this crucial nanomedicine – around 60 million vials are needed with an estimated value of more than $6 billion. The current multi-step, batch-based process requires the addition and removal of water and organic solvents, which is inefficient. It also limits the potential scale of its manufacture.
The solution
Dr Justin Tian is one of the inventors of CommandNano technology. He is also a co-founder of the company that is aiming to overcome the manufacturing issues of the nanomedicine by creating a one-step, solvent/water-free continuous nanofracturing platform. This would enable scalable production by halving costs, reducing manufacturing time from hours to minutes, and allowing interactive integration of design and process. The new process maintains product quality and by eliminating the use of solvents or contaminated water, it generates no toxic wastes.
CommandNano is also capable of synthesising other nanomedicine systems such as solid lipid nanoparticles, nanostructured lipid carriers and polymeric nanoparticles. It can also encapsulate small organic molecules, large biological molecules and inorganic nanoparticles.
The technology has already received £500,000 of financial support and is now looking to form a partnership for pilot scale clinical manufacturing. In the coming years it intends to conduct a bioequivalent study on liposomal amphotericin B nanomedicine. It will also file an FDA application in the US for producing generic drugs.
Dr Tian says: “The Enterprise Fellowship has enabled to me to actively engage with companies and organisations within the nanomedicine supply chain. It has also identified the key challenges in relation to the scale-up and commercial production of liposomal nanomedicines.”
Traction
2016 NSF-SFI centre-to-centre research project on continuous manufacture of nanopharmaceutics
2017 Invest Northern Ireland Proof-of-Concept project
2018 Ex-vivo nanomedicine comparison
2019 Innovate UK ICURe programme
2019 Dr Justin YW Tian was awarded an Enterprise Fellowship
2020 The company made an international patent application for its process platform and formulation