When scientists at the University of California, Berkeley (UCB), found a way to genetically engineer yeast to produce artemisinic acid, a precursor to artemisinin, they knew their discovery had the potential to fulfill a critical global health need—the stabilization of artemisinin production for malaria treatments. Nine years later, we are celebrating the launch of industrial-scale production of semisynthetic artemisinin at a new Sanofi factory in northern Italy. We caught up with our global program leader, Dr. Ponni Subbiah, who is taking part in the event.
Q. With the launch festivities wrapped up only a few hours ago, can you give us your highlights of the events today?
A. This morning, guests of Sanofi, our project partners, representatives of Roll Back Malaria and the Global Fund, and many other supporters gathered for a conference at Sanofi’s facility in Garessio, Italy, formally launching the industrial-scale production of semisynthetic artemisinin. Among the presenters at the conference was Dr. Jan Van Erps with Roll Back Malaria who spoke about the importance of semisynthetic artemsinin to ensure access to malaria care worldwide. The passion and dedication of the process development and manufacturing team at Sanofi was evident throughout today’s event. This included a tour in which we hopped aboard small trains (think of the train at Disneyland and you’ll have an idea of our ride!) for a tour of Sanofi’s new plant where semisynthetic artemisinin is produced. We saw the large photochemistry reactors where the final steps in the semisynthetic artemisinin production process occur and actual barrels of semisynthetic artemisinin ready to be shipped. The enthusiasm and excitement were contagious. One senior Sanofi colleague even indicated that this has been one of the most satisfying and fulfilling projects he has been involved in during his career.
I’m very grateful to Sanofi for hosting this event and bringing the partners together to commemorate this major milestone in the fight to eradicate malaria. Their hospitality has made this long-awaited celebration memorable.
Q. Nine years ago, the project was still an ambitious idea at UCB’s research lab in California. Today, you were standing on the factory floor at Sanofi’s plant in Italy, ready for large-scale production. What did it take to bring this innovative idea to scale?
A. Strong partnership and cross-sector collaboration. From the original technology that provided the basis for this work, to the development of fermentation, chemistry, and scalable industrial manufacturing processes to get to semisynthetic artemisinin, our partners demonstrated ingenuity, scientific innovation, and willingness to work together toward a common goal of malaria eradication. We couldn’t have gotten here today without the talents and key contributions of each of the partners involved.
Q. What was the role of OneWorld Health, PATH’s Drug Development program, in this project?
A. We led the partnership, providing overall program management and governance from research to commercialization. As the project grantee, we managed the interaction with the funder and facilitated communication between project partners; led strategy for product development, communications, and regulation; led the selection of the manufacturing partner; provided legal analysis for intellectual properties; and ensured that appropriate licenses and contracts were in place. We’ve also served as the public spokesperson for the project, keeping close contact with key stakeholders to ensure that the nonprofit nature of the project is well understood, and to promote the acceptance of this new technology and the smooth uptake of semisynthetic artemisinin.
Q. This project involved very diverse partners. What was it like working together despite varied institutional objectives and goals?
A. The partnership included a diverse group of experts from the nonprofit, academic, biotech, and pharmaceutical sectors. As institutions, naturally, we have different ways to measure our success. Research scientists are rewarded for agility in research and publishing; an industry partner at a startup phase is rewarded for proof of concept of their technical platform; a pharma looks at commercial targets and getting products to market; and as a nonprofit, we strive to make a difference in public health. We realized our differences when we joined forces. At the onset of the project, we evaluated our differences and worked to harmonize them. We developed a set of shared standards for the project, identifying a common mission to keep our focus sharp.
Q. What was the most memorable moment of the launch event?
A. Seeing everyone together in one place celebrating this success—it really hit home the scale of what we have been able to do through our sustained cooperation, dedication, and most importantly our mutual respect for one another. Getting to see the fruits of that labor here in beautiful northern Italy, in Garessio, has been astonishing. What we have been able to accomplish—bringing semisynthetic artemisinin to fruition, first in the lab and then on an industrial scale—is truly incredible.
Q. What does it mean to you personally to see semisynthetic artemisinin enter the market?
A. When I worked at Mulago Hospital in Kampala, Uganda, I saw many patients suffering from malaria, including pregnant women and young children. I witnessed the critical need for meaningful treatment that would be accessible to patients, both in terms of supply and cost. Our work to diversify and strengthen production streams of artemisinin plays an important role in meeting that need. Semisynthetic artemisinin will strengthen the global market with an additional stream of high-quality product, giving ACT manufacturers a reliable supply they can depend on from year to year. By stabilizing the market against the fluctuating supply and pricing of botanical artemisinin, we’re making lifesaving treatments more available to vulnerable populations. This is the most fulfilling aspect of this work.
Read the full press release about the launch of industrial production of semisynthetic artemisinin.
Photos: PATH/Ponni Subbiah