There are currently a wide range of nanopharmaceutical products in development across Europe. However, in nanomedicine, the scale-up of production from pre-clinical, laboratory scale to the quantity and GMP quality needed for clinical testing is severely hindered by a lack of pilot manufacturing capacity and supply chain infrastructure.
The quantities required for clinical testing studies are modest (in the order of 10 to 100 grams), but such pilot processes do not fit easily into existing manufacturing plants. The lack of a pilot manufacturing supply chain is especially problematic for SMEs and other organisations that do not have the necessary resources to develop the processes in-house.
NANOFACTURING proposes an ambitious multiple-scale, manufacturing platform to support the extensive pipeline of nanopharmaceutical products being developed in Europe. It will address the small- and medium-scale needs of early phase clinical trials and niche applications, whilst also supporting later stage products with large potential markets, by developing clinically compliant, sustainable large scale manufacturing processes capable of taking these products through Phase III trials into commercial manufacture and supply.
There has been significant progress in the nanomedicine field, with a number of new products showing considerable potential for more effective and less toxic treatments. However, progress to date in translating these innovative medicines into commercial success stories is currently limited by the inability to manufacture batches of the nanopharmaceuticals at the required scale and in line with stringent quality control measures required for medical products. NANOFACTURING will create value by enabling the progression of a pipeline of essential nanopharmaceuticals through clinical trials, whilst also de-risking the capital expenditure associated with the installation of the industrial scale process plant, particularly helpful for SMEs.
Once developed, the project outputs, which will include technology, expertise and open access manufacturing lines at pilot and large scale, will be available to support the effective translation of other early stage nanopharmaceuticals showing high potential, into effective and safe medicines that can be supplied at the quantities required.
Nanofacturing has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 646364.