On-Demand Flexible Pharmacy Manufacturing in Extreme Environments

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

Abstract

The world's space agencies have formed the Global Exploration Roadmap for the long-term human habitation of Mars. Achieving this goal requires adventurous manufacturing solutions across interdisciplinary boundaries of the engineering, physical and health sciences.

When taken ill, it is a quick trip to the pharmacy...unless you are in space. For short space missions, it is feasible for an astronaut to carry general medicines to alleviate symptoms until they can return to Earth. 'Med Kits' for the Space Shuttle included small supplies of painkillers, antibiotics, antiemetics, etc. and the ISS has on board a reasonable assortment of medications, including IV and IM injectables, to cover an increased range of medical problems. A medical emergency and the necessary pharmaceutical intervention of an astronaut in Earth orbit can be accommodated by an aborted mission and early return. Such is not possible from planetary transit or from lunar or planetary habitation.

What if small quantities of pharmaceuticals could be made onsite, in space and on demand; an "Astropharmacy"? Health systems in space need self-sufficiency - such as the ability to manufacture and test pharmaceuticals. They also need to be efficient, limiting waste and recycling materials where possible. Here, we propose to create and develop the innovative manufacturing capability of flexible on demand pharmaceutical production. Using the protein machinery of cells we will develop cell-free drug production in microfluidic system that can operate in the extreme conditions of space flight. We will incorporate novel in process quality control methods to ensure purity and functionality of the pharmaceutical. We propose the innovative use of paper to create a 'drug factory' which can be applied to the skin to delivery of the drug directly to the patient as it is made. Finally, we will demonstrate the concept of telepharmacy, where the design of a biopharmaceutical can be transmitted from one site and the drug manufactured at the remote site.

Planned Impact

The UK Space industry has posted >6.5% growth in each of the past ten years with current economic forecasts suggesting that the UK's growth targets, if met, will yield a £192 bn/p.a. increase in the sector. Globally, the world's space agencies have agreed a global exploration roadmap the cornerstone of which is maned exploration and habitation of Mars. This combination of facts demonstrates that an opportunity newly available to the UK is the ability to provide leadership on the scientific basis of colonizing Mars. Providing this leadership will help boost the sector further, with job creation and financial benefit to the economy.

If the world's space agencies are to meet their stated goal for the long-term human habitation of Mars, there needs to be a change in the way that healthcare is provided. The research proposed here will demonstrate the feasibility of on-demand pharmaceutical manufacture in an extreme environment, thereby removing the limit to the time that man can be away from Earth-bound or manufactured-on-Earth pharmaceuticals. Weight restrictions of space flight necessitate flexible on-demand production with a focus on recycling and reusing material where possible. Such practices will have direct positive impact on the financial and environmental cost of production on Earth. Overcoming the problems of providing pharmaceutical care to astronauts in deep space and colonists of new worlds has direct impact here on Earth, with military personnel and explorers alike facing the prospect of many months, if not years, in the harsh environment away from pharmacy. The research proposed here will impact the health and wellbeing of people in remote locations for prolonged periods of time, and extend the time and distance that man can operate.

The ability to monitor and assure the quality of cell-free expressed biopharmaceuticals as they are made will have a positive impact on the biotechnology and pharmaceutical industry by moving from a batch production to continuous manufacture of protein with the increased flexibility and decreased time and costs that such provides.

Publications

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