Reshaping reagent supply chain using open-source biotech

The global supply chain for diagnostic reagents (the chemicals and enzymes that enable testing for infectious disease) is broken. COVID-19 has brought this issue - which was already a day-to-day reality for all researchers and healthcare professionals in the global South - to international attention. The result is severe underdiagnosis and the inability to make informed policy that balances public health with preserving already fragile economies and livelihoods.

Diagnostic tools are essential not only during a pandemic: quality-assured diagnostic tests are the primary lens to the practice of medicine, as without them, treatable and curable conditions cannot easily be addressed. Deploying these at the right time is especially important in fragile developing and emerging economies.

However, diagnostic manufacturing is concentrated in North America, Europe and specific parts of Asia (China, India, South Korea, Japan), leaving most of Asia, Africa and Latin America heavily dependent on the importation of test components which are disproportionately expensive compared to their purchasing power. For example, inequitable access to vaccines during the COVID-19 pandemic, described by the WHO Director-General as a “catastrophic moral failure”, provided a stark reminder of how health security in the global South heavily relies on solidarity from those countries with biotech innovation and manufacturing capacity.

Scientists in developing and emerging markets who are conducting vital research to understand diseases or developing health technologies such as diagnostic tests, drugs and vaccines might pay several times the list price and wait over one month (and sometimes up to six!) for delivery, often with recurring cold-chain disruptions. This heavily restricts their freedom to innovate with biotechnology to meet local challenges on their own terms and their ability to shape and benefit from the biotech revolution, which is expected to have economic impacts of up to $4 trillion a year over the next 10-20 years. 

Under these conditions, it is challenging for our peers to produce research with the urgency required to address local health demands. We are committed to changing this situation together.

Beneficial Bio is a global coalition of scientists working on a solution for the current supply chain challenge: an open-source manufacturing model for local production of test reagents to international standards that are lower-cost, faster and adapted for use in resource-limited contexts. We aim to increase the technological autonomy of countries in Latin America, Africa and Asia, and reduce distribution time and overall costs of test materials by up to 90% which would help save thousands of lives and drastically increase diagnostic preparedness and response capacity.

Our solution is a combination of technology and novel partnerships. We have synthesised an open-source toolkit of DNA that produces diagnostic enzymes, using renewable and globally accessible materials. We are also developing a Reclone Manufacturing Blueprint including detailed Standard Operating Procedures and template Quality Assurance documents to assist local producers to use it and meet international standards for in vitro diagnostics manufacture. 

We then transfer this package of technology to a resilient network of impact-focused, locally-owned biotech social enterprises (“nodes” -  public/private partnerships operating as collaborations between universities, national public health laboratories and local biotech companies) with full training for production, quality assurance and business development. It will rapidly enable the production of diagnostic enzymes in the bacteria Escherichia coli using “tried and tested” techniques. 

In 2019, Beneficial Bio co-created the first independent biomanufacturing enterprise in Cameroon, Mbolab Biotech, capable of fulfilling Cameroon’s demand for PCR products. We employed 6 local scientists and professionals, trained 9 master students, kick-started an ambassadors programme for early career researchers, and partnered with 11 local institutions, plus the Ministry of Scientific Research and Innovation. >10 students are currently working in our bioinnovation lab on aquaculture, infectious disease and agriculture projects that would not be possible without that provision. 

Meanwhile, our node in Ghana has bootstrapped labs and undertaken biomanufacturing training. Scientists from 6 further countries attended task force meetings to expand the model. In Kenya (and soon Ethiopia), we are building “AfriBIOHub” labs to enable local bioinnovation and host a Beneficial Bio manufacturing node to supply agricultural innovators in East Africa.

To more broadly address ecosystem-building for biotech innovation, we also consult on the establishment of bio-innovation hubs (shared lab facilities) alongside biomanufacturing training, reagent production and bio-entrepreneurship courses. 

Altogether, we believe this is a unique solution in terms of our integrated approach to technology, community and enterprise. Our approach enables rapid redistribution of material from any node and accelerates development through collaboratively sharing know-how. We now have partners in Chile, Colombia, Peru, Argentina, Cameroon, Ghana, Ethiopia and Kenya, who are starting to manufacture enzymes. 

All of the Beneficial Bio support team and nodes are biologists with direct or indirect experience of the supply chain problem and lack of access to reagents. We are part of the impacted community as researchers, innovators and international collaborators. Inequitable access to scientific tools is a long-standing problem in infectious disease surveillance that we are deeply committed to addressing through more decentralised strategies.

We currently benefit researchers and students at universities and research institutions undertaking health research (such as disease surveillance to inform public health interventions) and developing new biotechnologies. They are able to accelerate and scale up their research, which ultimately benefits local communities through an improved understanding of local health needs, better health technologies and other products addressing the SDGs. 

As we develop appropriate diagnostic quality management systems, we will more directly benefit patients through more sensitive, specific and timely diagnosis via public and private medical laboratories who will benefit from more affordable, faster and more reliable supplies. Ultimately, our solution serves those seeking an accurate diagnosis. We expect this to increase regional preparedness for rapid containment of future epidemics. 

The researchers we support are not only in the health and biomedical field but are also using our products in molecular breeding programmes for higher-yielding or pest-resistant crops; mapping biodiversity for conservation; researching sustainable manufacturing processes for leather and many other applications that support the SDGs.

We retain an agile team, geographically well-situated (Cambridge UK) to support our nodes distributed globally, and work with talented expert contractors to drive forward projects, focusing on supporting peers and colleagues to overcome problems that we understand deeply.

Our Executive Director Dr Jenny Molloy is part-time alongside leading a group at the University of Cambridge and has 13 years of experience developing synthetic biology tools to address global challenges. Jenny has worked on open science since 2008 and the intersection of open-source scientific tools and sustainable development since 2012, after her work on the genetic control of dengue mosquitoes gave her insight via colleagues into the challenges of undertaking cutting-edge science in the global South. She has initiated and built extensive networks and research communities around the world and was awarded the 2022 Vice-Chancellor’s Award for Impact for developing open-source DNA toolkits for COVID-19 research, reaching 500 labs in >40 countries. Her expertise extends beyond research, as she is regularly invited to shape biotechnology policy. We are currently seeking a new full-time Executive Director and board with diverse expertise, including in business development in emerging markets, to help us recruit a team that can deliver both new social enterprises and our Fellowships programme.

Our full-time Scientific Programme Manager Rita Dias is in charge of scientific training delivery and partnerships. With 8 years of research experience across five different labs in Europe, she understands extensively the technical challenges involved in this field. Our Executive Assistant Roxanne Armstrong keeps our operations moving.

In Cameroon, Mboalab Biotech have a full-time core team that is the blueprint for future nodes: Executive Director Stephane Fadanka, Sales Manager Yanick Diapa and Operations Assistant Therese Ettah Minffih.

Many of our current and prospective node leaders have directly experienced the challenges we aim to overcome. For example, Stephane Fadanka (Mboalab) tried to develop an environmentally-friendly alternative to chemical nematicides during his Masters degree. Even after paying a high cost to order the reagents from South Africa, he had to wait for months before they arrived, which prevented him from finalising his research on time and delayed his graduation for more than a year. 

We are building out a network governance structure that will support and include our wider community partners as Beneficial Bio scales, in addition to the support of local scientist-led nodes being at the heart of our operational model. 

We believe that our partners are best placed to engage their own communities to participate in making change for climate resilience and we support them in that. For example, we have financially supported the work of our partners at Mboalab Biotech in Cameroon to run STEM education classes, public engagement workshops and other activities addressing biotechnology for the SDGs.

As such, the Beneficial Bio team is deeply committed to the problem we are addressing and the community impacted, with whom they have built substantial trust and reputation over the last years. 

We piloted the feasibility of our technology transfer model in Cameroon, where we supported a team of social entrepreneurs to establish MboaLab Biotech in 2019. They launched six locally-produced PCR reagent products in 2020-21, opened a shared innovation lab welcoming and training >30 students/researchers working on infectious diseases and immune responses, and were involved in three international research grants. Our products have been showcased in 11 research institutions across Cameroon and have been distributed to >50 customers.

To date, >250 members of this community have participated in our training courses, we have run 9 internships for Masters students in Cameroon and five internships for UK students who have visited LMIC partners (where COVID allowed). 

We aim to onboard at least three new Nodes in Africa during 2023 and expand to Latin America in 2024, accelerating the work of >500 scientists, each of whose own work has the potential to impact thousands of other people’s lives. 

Our pilot manufacturing node in Cameroon was a technology transfer success and we learned how to establish new organizations and develop lab facilities. However, we underestimated the challenges of rapidly creating sustainable organisations in emerging markets.

We used our experience so far to refine our Theory of Change (https://drive.google.com/file/d/1EhgefRxEDuGUZItnTFhl07bIxRa2vM_r/view?usp=sharing ) and develop impact Key Performance Indicators (https://docs.google.com/document/d/108wV7U1yApzNT-CDzHC7KU58ojSbi4J9MnvJ-_yHC4w/edit?usp=sharing ), including metrics such as the number of projects accelerated when compared to standard delivery times. We identified a critical need to include comprehensive business development assistance in our model, and are using these lessons to reshape our support package and node expansion strategy. 

That said, MIT Solve can help us connect with not only funders but, maybe most importantly, mentors that can help us review our strategies and elevate and scale up our solution. Interacting with other Solvers (as like-minded peers facing similar challenges) will also foster relevant breakthroughs and potentially help us connect with the wider community and “market” our solution to other entities interested in collaborating.

As a small nonprofit, Beneficial Bio doesn't get a lot of exposure, which is something we could benefit from and achieve through Solve. The distribution and commercialisation of any product requires quality assurance and trust from the consumer, and exposure via a highly regarded entity such as MIT can help build trust in the products arising from our solution and, ultimately, speed up technology and knowledge transfer.