New research aims to improve access to research capacity through on-site biomanufacturing

Keith Pardee and international collaborators biomanufacture robust, low-cost research and diagnostic tools in remote locations in Canada and around the world

New research from a team based at the Leslie Dan Faculty of Pharmacy, along with collaborators around the world, demonstrates the effectiveness of bringing bioproduction of low-cost, robust reagents to laboratory research and diagnostics in resource-limited settings. The paper describes hardware and molecular tools that may improve accessibility of life sciences research, thus empowering local innovation and improving research equity.

The research was led by Keith Pardee, associate professor at the Leslie Dan Faculty of Pharmacy, and colleagues around the world, including Camila González from Universidad de Los Andes in Bogota, Colombia, Fernán Federici from Pontificia Universidad Católica in Santiago, Chile, and Lindomar Pena from Oswaldo Cruz Foundation (Fiocruz) in Recife, Brazil. The study was published in Science Advances today.

“For labs in low- and middle-income countries, access to critical lab bioreagents such as antibodies, enzymes, and growth factors is a chronic problem. Shipping can take a long time, it’s expensive, and products often require a cold chain to retain their effectiveness,” says Pardee. “This research is in response to those challenges by bringing the production of these products into the hands of the researchers themselves.”

Such bioreagents are typically produced off-shore by a few global biomanufacturing hubs, which present barriers in both logistics and costs, and reduce life science research and discovery capacity.

Pardee and his team’s research focuses on improving access to research and diagnostic tools in resource-limited settings. Over the past several years, Pardee’s team has been developing synthetic biology and cell-free systems, which use the isolated and freeze-dried molecular machinery of the cell responsible for the synthesis of proteins. These freeze-dried reagents can then be shipped without a cold chain and reactivated when needed by adding water for on-site and on-demand production of proteins such as antibodies and enzymes).  To accompany this cell-free technology, the team has also been developing portable and adaptable hardware designed for small-batch biomanufacturing.

Building on this work, Pardee and collaborators’ new publication demonstrates the effectiveness of their cell-free protein synthesis and low-cost hardware in a variety of settings, from conventional labs to remote locations. Cell-free systems and standardized protocols enabled researchers to produce a variety of protein-based products to support lab research. This included a 3D-printed hand-powered centrifuge, developed by postdoctoral fellow Mohammad Simchi, and the production of high-value growth factors, a vaccine for SARS-CoV-2 tested in mice, as well as diagnostic tools for a number of clinically relevant pathogens.

“Our work shows that it is possible to produce high-value bioreagents on site, essentially anywhere,” says Severino Jefferson Ribeiro da Silva, postdoctoral fellow in Pardee’s lab and first author of the study. “Through this work, we demonstrated our tools across diverse international settings while maintaining performance comparable to commercial products.”

Researchers tested tools in remote areas of Canada and internationally

Key to the research was testing the tools in different settings, in Canada and internationally. In one case, da Silva tested the diagnostic tools for tick-borne pathogens and tuberculosis at a cottage in the Algonquin Highlands; in another, graduate student Quinn Matthews demonstrated local production of enzymes in the Yukon, including producing and purifying proteins using the cell-free system and a 3D-printed centrifuge on a mountain outside Whitehorse.

Collaborators in Chile, Brazil, Colombia, and India also tested the systems. The strong international collaborations – involving regular and frequent meetings, international student exchanges, and knowledge sharing – ensured that the teams considered the expertise and diverse perspectives of all collaborators to develop tools that would meet the needs and challenges of potential users.

Da Silva says that their research team got a taste of the challenges their international collaborators face when packages they sent containing critical reagents were delayed for weeks or months in customs and other materials were damaged during transit.

“Those experiences highlighted how dependent many researchers and labs still are on fragile international supply chains. If a shipment is delayed, an entire project can stop,” says da Silva. “This work makes it possible to reduce that dependency by enabling local production of key proteins directly at the point of need. The goal here is not to replace centralized manufacturing but to create more equitable and resilient distributed systems that can improve global access to biotechnology.”

In the long-term, Pardee says the goal is that research labs in low- and middle-income countries or remote settings will have access to high-quality research tools and diagnostics through on-site biomanufacturing, increasing resilience to disruptions in trade or supply chains. Ultimately, this would allow more countries to build their research capacity and address their local healthcare needs.

“This work is really about access and scientific empowerment. Many labs worldwide have the expertise and ideas to conduct life sciences and applied science research, but they face major challenges to accessing key bioreagents and other essential materials,” says da Silva. “In these cases, decentralized biomanufacturing could help reduce those barriers and enable more local innovation, making research and diagnostics more accessible globally.”