Foresight Fellowship in Manufacturing: Analytical technologies in continuous and additive manufacturing

Lead Research Organisation: University of Nottingham
Department Name: Sch of Pharmacy

Abstract

This Fellowship application seeks to accelerate the uptake of continuous and additive manufacturing in the pharmaceutical industry. Continuous manufacturing is widely used in many sectors, where just-in-time protocols are common. Additive manufacturing, encompassing 3D-printing, has received much attention recently as printers have become commercially available. Additive manufacturing is a very flexible process and is currently used predominantly for prototype manufacture, enabling personalisation of products. However, scaling-up additive manufacturing processes is challenging and the vision of scales-out (multiple printers or print heads) is often suggested. In contrast, continuous manufacturing processes offer a more direct route to scale-up and are also flexible; the same production line can be used to manufacture a number of different products. However quality assurance protocols in continuous manufacturing are challenging.

Many reasons are given for the pharmaceutical industry not adopting the latest manufacturing technologies, chief among these are regulatory concerns. This is in part due to innate conservatism from the regulators (though the FDA is encouraging change) but also due to a lack of analytical technologies being integrated with the continuous manufacturing production lines to ensure product quality. It is these analytical challenges that this Fellowship seeks to address.

Planned Impact

Society needs better medicines, produced on a cost efficient basis. To achieve this the pharmaceutical industry needs to implement the latest scientific and technological advances. The model of manufacturing in the pharmaceutical industry has not innovated in recent times and significant benefits will arise in terms of product flexibility and stratification if current state-of-the-art manufacturing capability is developed.
Addressing this challenge will lead to society as a whole benefiting as new medicines reach the market. The pharmaceutical industry will benefit as it is able to take a more flexible approach to manufacturing, improving efficiencies and reducing costs.

The integration of analytical technologies into continuous and additive manufacturing processes is likely to generate IP and so there will be benefits to the University and industry from exploiting the IP. There will be academic benefit from crossing disciplinary boundaries and also from working cross-sector.
 
Description We have developed continuous flow technologies for making micro- and nano-particles, both with small diameter tubing and using microfluidic chips.We have investigated entrapping small-molecule and biological drugs in the polymer micro- and nano-particles we have made.I have established links with AstraZeneca and GlaxoSmithKline and am working with the Department of Biochemical Engineering at University College London.
Exploitation Route The Fellowship has enabled me to expand my collaborative network and the research has been taken forward as part of the EPSRC Manufacturing Hub in Future Targeted Healthcare
Sectors Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology

 
Description Findings made during the Fellowship have been applied to develop a relationship with SureScreen Diagnostics. This has led to the award of one InnovateUK KTP and a subsequent KTP application.
First Year Of Impact 2016
Sector Healthcare
 
Description Future Targeted Healthcare Manufacturing Hub
Amount £10,000,000 (GBP)
Funding ID EP/P006485/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 06/2017 
End 12/2024