Multi-institutional Research Team Creates Portable, On-Demand Biomolecular Manufacturing Platform for DIY Therapeutics
September 22, 2016
Toronto, ON – As much as 80 per cent of the cost of bringing vaccines to the developing world comes from ensuring that the medications are properly refrigerated and transported. Most vaccines need to maintain a consistent temperature to prevent spoilage and maintain their efficacy, which necessitates a cold chain from production to application. Despite these precautions and the attention paid to their transportation, the World Health Organization and United Nations Children’s Fund estimate that the amount of essential vaccines that end up wasted could be as high as 50%.
Researchers at the University of Toronto, MIT, Harvard, and the University of Ottawa published a proof-of-principle paper in Cell today that addresses this issue by developing a platform able to manufacture on-site, on-demand therapeutics and biomolecules.
The new portable drug-manufacturing system uses two sets of freeze-dried components that, when mixed with water, is able to produce medications, therapeutics, and diagnostic tools virtually anywhere.
The first of these components is an innovative cell-free synthetic biology “machinery” developed by the team in 2014 that provides a manufacturing infrastructure where the end product is produced. The second component is DNA instructions that tell the manufacturing piece what compound to produce. This pellet can be customized to generate a variety of products, including vaccines, anti-cancer antibodies, and diagnostic tools. When the two freeze-dried pellets are combined with water, the production process begins.
“In essence, it’s like having a portable pharmacy that you can use to create the medications you need,” notes Assistant Professor Keith Pardee of the Leslie Dan Faculty of Pharmacy, co-lead author of the paper.
Through the simple act of rehydrating the components by adding water, vaccines, antibody-based drugs for cancer treatment, small molecules, and clinical tools like diagnostic systems spring to life, bringing tools and treatments to underserved populations across the globe.
The possible applications for this discovery, he explains, are almost endless.
“If, for example, the influenza vaccine developed in a given year is off target and doesn’t fight the strains of the virus that emerge, the system we’ve developed can address that. The current production chain for the influenza vaccine begins in late spring early summer for fall and winter application. If the formula is wrong, it would take months to change, produce, ship, and administer a vaccine that hits on the right strains.”
“Whereas with our system, in theory, once the proper strains are identified and a new formula developed, the vaccine could produced anywhere in a matter of hours. The materials would already be on the shelf – they’d just need to be programmed to produce the vaccine. While this is just a proof-of-concept study, this could mean no prolonged production time, no timely and expensive shipping.”
These freeze-dried components last for at least a year at room temperature, making shipping and storage easy and considerably less expensive than traditional means – even to the most remote areas. It also means that the products can be stored on the shelf, ready to be activated when an outbreak occurs or whenever the need arises.
“This technology could even be applied for use in remote Antarctic research bases or for something as fanciful as space travel,” notes Dr. Pardee. “If deployed in combination with a DNA synthesizer, the gene sequences that encode the manufacturing instructions could be electronically transmitted to remote end users, converted to DNA, and used to guide the cell-free manufacturing platform to produce therapeutics to meet unanticipated needs.”
“By freeze drying the DNA constructs and the cell-free synthetic biology system into a easily portable and long-lasting platform,” explains Pardee, “we’ve created a flexible tool that brings medication production outside of the lab, which has incredible potential for global health and personalized medicine.”
To read the paper, please visit http://www.cell.com/fulltext/S0092-8674(16)31246-6.
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Leslie Dan Faculty of Pharmacy
University of Toronto