Afrigen Biologics & Vaccines – An African Vaccine Hub

Afrigen is a company with a mission- to provide Africa with a fully localised latest vaccine development and production capacity. We learn how they do it.

Afrigen is a young biotech state-up company founded in 2014, with the mandate to localise the manufacturing of tuberculosis vaccines to South Africa.

“The core of its strategy is the localisation of vaccine production to the continent,” explains Professor Petro Terblanche. “We started as a Research and Development company, with a small team of five PhDs and an administrator establishing a platform for the formulation of essential elements of this vaccine.”

From these humble origins, the company became fully operational by 2020, when Africa had an urgent need for localised vaccine development. While the Covid pandemic was in full swing, Afrigen was bringing its facilities into production and getting manufacturing processes started. Using technology licensed from a US partner, Afrigen created the first ever adjuvant formulation centre on the continent with the capability to produce cGMP grade of a library of the latest adjuvants. Adjuvants are used in many vaccines to help create a stronger immune response.

Afrigen has already achieved a lot, but it is still early days.

“We are still in the pre-revenue status of our life cycle. We started with two shareholders, a development finance company, IDC, and a non-profit, the Infectious Diseases Research Institute,” Professor Terblanche tells us. “That’s quite unusual, but in 2018 the non-profit exited and the majority shareholder is now Avacare Health, a pan-African healthcare company started in 1994 which is now backwards integrating into manufacturing and R&D.”

Afrigen itself now boasts the capability to carry out vaccine innovation and manufacturing, not only establishing its own RNA platform but also acting as an RNA technology transfer hub for the continent and other low-middle income countries (LMICs).

“Our company entered the market with the capacity to allow vaccine development from the design of the vaccine right through to clinical trials and further development. It is a unique capability for low-income countries,” Terblanche says. “Our purpose is to offer a combination of discovery, research, right through to market relevance and the production of GMP grade material and a microbial base for RNA. We operate in the One Health sphere, for human health and animal health, developing products with the same platform suitable for both applications. That is quite unique.”

This is the short version of the story, but it begs the question, how has Afrigen gone from being a start-up in a lab with a handful of people to being a critical part of the continent’s vaccine infrastructure?

From Start-up to Technology Hub

In the beginning, like most start-ups, the first challenge Afrigen faced was raising capital. It is particularly difficult to source capital in Africa, where there is not a venture capital market, so the firm had to rely on development finance corporations or bank loans, which required collateral.

“We’ve learned that the number one reason for failure is to not have enough working capital, taking into account the long lead times before products reach the market,” Terblanche points out. “So, our earliest challenges were access to years of working capital to develop the technologies we needed. We found a shareholder, and one of their unique components was their willingness to take risks and fund working capital.”

With its immediate future assured, Afrigen finally came to prominence in 2020, when it was announced that mRNA vaccines would receive emergency market authorisation. Afrigen responded by strategically building a facility for mRNA vaccines, aligned with the Afrigen formulation capabilities to formulate lipid nanoparticle formulations for mRNA vaccines.

“We had a strategic view that if we could prove our platform was suitable for rapid response vaccine development, that would be a strategically valuable capability to have, particularly in Africa,” Terblanche recalls. “So, we built it and looked for a technology partner to licence the latest mRNA vaccine technology to us.”

Afrigen would play a crucial role here, not just bringing the technology into the continent to develop themselves but building a network of partnerships that will contribute to vaccine innovation and manufacturing on the African continent to Africa’s entire pharmaceutical industry.

The WHO mRNA programme is a ‘hub and spoke’ model. We were busy building the infrastructure for our facility when the Covax Initiative put out a global call for companies to become global mRNA hubs to receive technology, develop vaccines and transfer that technology to other ‘spokes’,” Terblanche says.

To do this, Afrigen partnered with other key organisations.

“Early on we realised we would be operating at development scale and would be able to make clinical material, but our capacity would be 50 million doses and we needed much more,” Terblanche says. “So, we partnered with the Biovac Institute which had capacity for 200-300 million doses, a foremost vaccine manufacturer and supplier in the country.”

While the mRNA platform was established the SAMRC is working with Afrigen and partners to build a network for vaccine R&D and start researching a pipeline of products, which Terblanche knew would be essential for long-term sustainability in Afrigen’s tech hub role.

“We couldn’t establish a platform on a single product, we needed a pipeline of products,” she tells us. “We hit the ground running because the call was for pandemic response and there was an urgency to fast-track vaccine production in low-middle income countries. The South African proposal had three strategic partners, the tech transfer and development entity (Afrigen), the first commercial spoke (Biovac), and the Medical Research Council for leading novel mRNA vaccine research.”

Following due diligence and many discussions, WHO and other partners selected Afrigen as the global mRNA tech transfer hub and secured non-dilutive funding to fast-track the establishment of the hub, fundamentally changing the company’s growth speed and strategy. In 16 months, the company went from 22 people to 34, with the company recently hitting a workforce of 70 people, with more growth promised for the near future. Afrigen has expanded its facilities with an additional 2,000 square metres of high-tech facilities, including cryogenics, sequencing facilities, and creating plasmids right through to finished drug product for clinical trial materials – creating a complete value chain.

Of course, to fuel that growth, Afrigen needs the right people.

“Our challenge now is to get access to the necessary skilled and experienced workforce. We are building a unique sector in Africa, drug substance production. Few companies in Africa can do that,” Terblanche explains. “We are taking on the entire sector, end-to-end. The challenge is finding manufacturing personnel at the supervisory level with relevant industry experience. We have to bring in people from university well trained in an academic knowledge base but without experience in the vaccine manufacturing space, so that is our biggest challenge now.”

The key is creating a space where people want to work.

“We recruit through word-of-mouth, it’s a small community,” Terblanche says. “We create an exciting work environment that is stimulating, conducive for personal growth, and enjoyable. We run facilities where people can excel and grow.”

When we speak with Terblanche, she is preparing the company to achieve its most stringent technology licence yet, with the goal of eventually making Afrigen a CDMO operating under a contract development organisation model.

In the short term we are incredibly focused now on developing the first mRNA vaccine on the African continent and taking it through to clinical trials,” Terblanche reports.

Longer term, Afrigen has much bigger plans as it readies its Covid-19 vaccine for the market.

“We are part of the biggest tech transfer project in the history of vaccines, a multilateral transfer to create capacity and capability for low-middle income countries and companies to develop mRNA vaccines for pandemic preparedness and vertically integrated, decentralised vaccine development,” Terblanche tells us. “Our primary focus is on unmet needs, and with our shareholder who has massive distribution networks extending into all continents, we will take our products to market. Five years from now I see us becoming fully integrated with at least two vaccines in development and one in the market and a portfolio of 15 unique applications for human and animal health.”

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