From Discovery to Delivery: Interview with Petro Terblanche – Chief Executive Officer, Afrigen Biologics, South Africa

Meeting highlights:

• GMP Milestone & End-to-End Capability: Afrigen is on track to receive its GMP license in 2025, completing its end-to-end capability from R&D to GMP manufacturing, allowing it to bring novel vaccine candidates to clinical trials and the market. 
• Pan-African Tech Transfer: Afrigen is a core part of a landmark mRNA technology transfer initiative, having already trained seven of our 15 partners of the WHO/MPP mRNA TT Programme, including institutes and companies in Tunisia, Senegal, and Egypt, making it the only African company transferring biotech platform technologies for innovation and manufacturing to other African entities. 
• Diverse Vaccine Pipeline: The company’s expanding pipeline projects include vaccine candidates for RSV, TB, Rift Valley Fever, mpox, gonorrhea, and H5N1—all part of collaborations locally and internationally using cutting-edge technologies such as AI-driven design. 
• Funding Challenges & Strategic Response: Afrigen is navigating a shrinking VC and donor funding landscape by repackaging its portfolio for commercial viability, emphasizing blended funding and collaboration to de-risk R&D. 
• Vision for African Health Sovereignty: Petro strongly supports the AU’s 2040 goal of producing 60% of Africa’s vaccines locally, stressing the need for political commitment, multi-sectoral regional harmonization, public-private investment, and preventative health care policies. 

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EF: 2025 is an important year for South Africa. How do you see this year from your perspective, and what can we expect from Afrigen? 

PT: This year, we are focused on fast-tracking commercial operations and repackaging our portfolio to ensure that, even without certain funding, we can advance our assets towards clinical readiness. At the same time, we must ensure our shareholders still see the value being created. 

The highlight of the year is that this is our GMP certification year. We're on track to obtain the GMP license, which will enable us to conduct end-to-end operations, from discovery and development through scale-up, preclinical development, and GMP manufacturing, under a SAHPRA 22C license. This supports filing for an IND (Investigational New Drug) or CTA and includes an end-to-end manufacturing process from drug substance and drug product to fill finish in vials ready for human use and meeting quality standards for safety and efficacy. It's a unique, complete value chain for Afrigen. This is a pivotal year for us. We hope to advance at least two vaccine candidates toward clinical trial readiness. 

We face a delicate balance as a pre-revenue earning entity, building assets geared toward tech transfer and collaboration with continental partners. That balance between non-dilutive grant funding to de-risk early-stage development and shareholder funding is sensitive. In the past four or five months, funding has been withdrawn for some of the products we're developing, such as those for HIV. This directly affects how we sustain the platform. 

So, while it's a challenging funding landscape, it's also a year full of highlights and progress as we remain focused and driven. 

EF: Can you elaborate on your exciting pipeline and tell us what is coming up? 

PT: Let me start with the current platform. We are building this platform, and are steadily on route to fully establish the platform through developing a novel mRNA product from concept to licensure. We need to validate and demonstrate that it's suitable for developing a safe and effective vaccine through an extensive process and product development experiments and have to date completed the preclinical development and non-human primate studies on our first vaccine candidate. We've demonstrated that our platform is compatible with and compares favorably to commercially available vaccines, which is very important to us. 

We used the AfriVac2121 COVID-19 vaccine as our Trojan horse to demonstrate this, which has been a key milestone. Now that we've completed the demonstration, we've begun transferring our technology to partners, which is a major step forward. The mRNA TT Programme is the largest tech transfer program in the history of any product, not just vaccines – platform technology transfer to 15 partners on four continents, representing 3 billion people to contribute to a better-prepared global South for future pandemics. And simultaneously creating global networks for R&D to develop new mRNA vaccines for public health protection. This is very ably led by the WHO and MPP. 

What's unique is that the technology package being transferred is carefully customized to suit the readiness level of each partner. Traditional tech transfers are typically bilateral, company-to-company, with fixed rules: strict timelines, costs, and license conditions. However, we've adopted a more flexible approach because our goal is to improve access and pandemic preparedness alongside long-term product development and commercialization. 

Depending on each partner's capabilities, we've started transferring the technology in scalable formats, from small to larger volumes. So far, we've worked with seven partners. Every month, for three weeks, a partner joins us in the lab: we train them, they produce their drug substance, conduct analytics, formulate the drug product, return home, and begin implementation. We then confirm their progress and that the validation step is crucial. 

We've already completed transfers to three African partners: Biovac as first partner followed by Institut Pasteur Dakar and Institute Pasteur Tunsia. Three more are upcoming: BioGeneric Pharma, Biovac Kenya, and BioVaccines Nigeria, and we'll proceed as they become ready. To my knowledge, Afrigen is the only African company that has transferred vaccine technology to other African companies. 

Secondly, we've demonstrated that our platform supports interchangeability between variants, including the COVID-19 XBB 1.4 variant and the original Wuhan monovalent strain. It was vital to show that the mRNA platform can adapt to different variants of the same disease. We've also expanded our portfolio. All of these are partnership-based projects. Afrigen hasn't undertaken any of them alone. That's partly because we value collaboration, but it's also a cost-effective strategy. When we lack access to a specific technology or component of a process or need the freedom to operate independently, we bridge those gaps through partnerships rather than attempting to do everything ourselves. 

The Rift Valley Fever initiative is a beautiful project. In this initiative, we’ve worked with genomic surveillance and sequence data provided by Prof Tulio de Oliveira and his collaborators in other African Countries such as  Nigeria. Rift Valley fever is a priority pathogen in Africa due to its pandemic potential and high mortality rate. It’s a zoonotic disease and part of CEPI’s global pandemic preparedness priority list because of its potential to spill over into a pandemic, something we want to prevent. 

Using all the published sequence data, our scientists at Afrigen analyzed, tested, and designed a vaccine with a unique sequence composition. That candidate is now in mRNA form under two CEPI-funded projects. The first focuses on how we can increase the speed of manufacturing in line with the CEPI 100-day mission by using synthetic DNA versus plasma DNA as a key manufacturing step. The second focuses on advancing the candidate to clinical trials to demonstrate safety and efficacy for Rift Valley fever. It’s a very exciting and fully CEPI-funded project. It’s one of the few examples globally where the journey from sequence data to vaccine candidate in the clinic has been completed within a single country through strong partnerships.  

Now, regarding RSV: yes, there are already vaccines from Moderna and Pfizer, and while those are good, they're expensive and currently mainly available in high-income countries. There is still space for a locally produced RSV vaccine demonstrating strong safety and efficacy. We are making some improvements in our vaccine product and process, adjusting the RNA components to enhance potency, durability, and, most importantly, thermostability. We aim to avoid cold storage requirements like -20°C or -80°C. We're continuing with this work, and on May 14th, there will be an announcement about the funding we've secured from a European Country supporting vaccine innovation and capacity building in Africa. So it's a promising project for us. 

The third project is tuberculosis. UCT and WITS have initiated discovery and identified four promising antigens, suitable for mRNA process development. Afrigen is scaling the process to optimize and prepare for GMP manufacturing and aiming to drive this into clinical development within 12 months. This collaboration between WITS, UCT, SAMRC, and Afrigen is another example of how public-private and academic partnerships can accelerate vaccine development. One of Afrigen’s key contributions to South Africa, which didn’t exist before, is the translational capability we’ve now built, the ability to move from discovery to clinical development and GMP manufacturing. And we’ve been able to do that thanks to our strong partnerships and funders. 

The fourth project is on MPOX, and it's particularly interesting. We're working with partners at UCT and a company in the United States that uses AI and sophisticated antigen design. We've designed a pox vaccine candidate targeting T-cell and B-cell activity. While those technical details may not matter to everyone, this approach could offer broad protection across different strains. The project is still in its early stages as we move toward creating an mRNA construct. There will be a funding announcement on the 14th of May, supported by a European government, which will help advance this work. We were also preparing the process development and scale-up for one of the Brilliant Consortium (led by Prof Glenda Gray) HIV vaccine candidates, which USAID initially funded. Unfortunately, that work has been paused, and we didn't continue. However, we are regrouping and working closely with the South African Medical Research Council and other funders to ensure the HIV project can resume. At the moment, it remains in limbo. 

Next, we're very excited about our gonorrhea vaccine. This project targets antimicrobial-resistant gonorrhea, a growing global health issue. We've partnered with a Danish company that uses AI to design the antigens, which form the fundamental input to vaccine development, and this work is already in the public domain. We've achieved preclinical proof of concept, and the data is promising. We're now fast-tracking this project and sourcing funding to move it into clinical trials. This vaccine is globally relevant, and the mRNA constructs have shown excellent results compared to other platforms, so we're truly excited about its potential. 

We're also involved in an H5N1 avian flu project led by Sinergium our Argentina partner in the mRNA TT Programme. Our mRNA platform has been transferred to Sinergium in October 2024. They are one of our partners that has made the fastest progress in adopting this technology. Sinergium is leading a consortium to develop an H5N1 vaccine, and they've already seen encouraging results. Afrigen is collaborating closely with them and with Hilleman Laboratories in Singapore to develop this vaccine as a key pandemic preparedness project. Afrigen will assign scientists to work directly with Sinergium in Buenos Aires to support this effort. The goal is to develop a broadly protective vaccine against avian influenza. 

Beyond that, we're submitting proposals with many partners and awaiting funding for additional projects on hookworm, river blindness, a non-RNA TB vaccine, and rabies. These efforts reflect our broader strategy: demonstrating that our mRNA platform is pathogen-agnostic. This means we can use it to develop vaccines for viral, bacterial, and parasitic diseases and potentially for various conditions. We're also beginning early discussions on expanding into therapeutics. While the infectious disease vaccine market is crucial, it can also be complex and challenging to sustain. In contrast, therapeutics, especially monoclonal antibodies, represent more versatile and higher-value products. So, we're also beginning to explore how we can leverage mRNA for therapeutic applications. 

EF: How do you see the ambition of the African CDC to produce 60% of the continent's vaccines by 2040, and how can we get there, and who needs to come together to make this happen? 

PT: What's critical is having a clear roadmap to reach that ambition. The Africa CDC is doing a commendable job. They keep the ecosystem cohesive, push boundaries, challenge governments, and drive momentum across all sectors. Despite recent challenges, particularly with funding changes, they stay the course. I strongly believe in their strategies and how they aim to consolidate efforts across the continent. 

Of course, progress won't be uniform in a complex ecosystem like ours. Some regions will inevitably move faster than others, and that's to be expected. The developments with AVMA and Gavi, for instance, are significant. Likewise, collaborations between Biovac, the World Health Organization, and SAHPRA are important case studies, especially to fast-track GMP licensing and WHO prequalification for oral cholera vaccines after the tech transfer from IVI. They show we could expand the vaccine portfolio with six strong initiatives. Reaching the 60% local manufacturing target is not impossible, but it will likely begin with pediatric and existing vaccines within established markets. 

That said, we operate in a different space. Six to eight capable companies must robustly drive the first wave of vaccine manufacturing. These include, amongst others, Biovac, Aspen, IPD, BioNTech Kigali, BioGeneric Pharma, Vacsera Egypt, and DEK Vaccines in Ghana. These initiatives must succeed and are supported through blended financing models. Regulatory authorities who have signed MOUs on reliance and harmonization must follow through. We shouldn't have to submit six dossiers for six countries. There should be one dossier and a unified process.  

True commitment is backed by action, not just words, which our governments must do. Mentioning support for local manufacturing is not enough. We need to see tangible investment and action from governments. It is not about making demands or issuing threats. It's just the truth. If African leaders are serious about building strong, resilient health systems, they must shift their focus from merely managing diseases to prioritizing prevention. That's how we create long-term social and economic value. 

The current model of managing the triple disease burden is financially unsustainable for most African economies. However, the socio-economic conversation will change entirely if we focus on prevention through clean water, vaccination, lifestyle changes, and education. These conversations are beginning to happen, but they will require a fundamental shift in our thinking, how we structure and invest in healthcare, and how we foster local manufacturing for all healthcare products, not just vaccines. 

Turning to Afrigen, how do we prioritize which vaccines to develop? Take HPV, for example. It prevents cervical cancer, yet we still haven't achieved full coverage with the vaccine. Then there's gonorrhea, another significant public health issue. RSV is also critical. Maternal vaccination can prevent infant hospitalizations in the first six months of life and significantly impact adult life expectancy, particularly among vulnerable groups. We need to prioritize vaccines that are preventative in nature and direct funding and support towards their development. But we're not doing enough of that yet. That's the next wave I want to focus on, not just existing products into existing markets, but also new products into existing markets and new products into new markets. These are the fundamentals we must return to. 

Governments must honor the treaties they sign. In Abuja, 54 countries committed to investing 15% of their GDP into healthcare. Yet, only Botswana and Rwanda have met this target two years later. There must be a real commitment. It’s the same principle as business: I follow through if I present a business plan and agree on milestones and deliverables with my funders. We need that same accountability from our governments. 

Similarly, investment in research and development is critical. The target was set at 1% of GDP, which may not be realistic for all, but could we manage 0.5%? That would already make a significant difference. Government prioritization of industrialization and socio-economic development is essential if the continent progresses as a unified force. From a regulatory standpoint, we’ve made impressive strides. SAHPRA, for instance, has been one of our standout success stories over the past three years. 

Let’s also talk about venture capital (VC) funding, which is key to understanding why I advocate so strongly for it. When we look at companies like Moderna, BioNTech, and CureVac, these global leaders emerged from environments rich in VC support. In the U.S. and Europe, there’s a healthy risk appetite. University spinouts don’t just launch and vanish after Series A; they’re supported through the full development pipeline. That kind of structure doesn’t exist yet on the African continent. 

I recently read the 2024 VC investment report for Africa. It was both exciting and disheartening. In 2022, $3.3 billion was invested in startups across the continent. In 2024, that dropped to $1.1 billion. More troubling is that none of the 200 companies invested in were in manufacturing. The focus remains on FinTech, HealthTech, e-health, and ICT sectors that require lower upfront investment, reach the market faster, and, if they fail, do so quickly. As these sectors are important and as start-ups on the continent created more than 20,000 new jobs in 2024, we need to fund manufacturing startups with blended funding and focus on next-generation technologies and advanced therapies. 

Biotech is different. It may take five years for a biotech company to fail, but it also takes ten years from zero to hero. Building sustainable assets on the continent will be difficult without targeted VC funding for biopharmaceutical and biotech manufacturing startups. Biotech creates long-term assets, new products, solutions for unmet needs, and economic value. So, our sector must build these assets for Africa's future. 

EF: What are you most excited about right now? 

PT: Our biggest celebration of this year will be for the GMP license because that will be the moment that completes us. It marks our readiness to bring commercial products to market and our ability to apply our scientific discoveries to clinical applications. Looking at our portfolio, I'm genuinely excited about its diversity. It's a rich, multifaceted pipeline, but if you ask me what excites me the most, it's my people. Watching them grow, excel, and make discoveries is inspiring. This is truly a dream team. Even more remarkable is how we've evolved into a horizontally integrated unit from basic scientists to regulatory and quality teams. It's a deeply connected and highly dynamic group.  

EF: What is your final message to our readers? 

PT: It will take the whole village to make it happen. As a continent, Africa can't afford to step back now, as there's so much at stake. This is about our health and future; there's no turning back. It's hands-on for all stakeholders, with every voice and all our energy, focused on one common goal. Let's get to work with all hands on deck.