Africa still imports 99% of its routine vaccines and 70–90% of its biopharmaceuticals. The Africa CDC warns this vulnerability could cost the continent up to $1.1 trillion in skills and jobs through 2050.
This is motivating a biotech revolution building up in South Africa—the continent’s most industrialized nation where startups are confronting “pharmaceuticals apartheid”—tinkering with low-cost, decentralized biotech R&D and manufacturing prototypes.
So much is at stake and urgent, said Nick Enslin, co-founder and COO of Immobazyme, one of the flagship South African startups that specializes in advanced biomanufacturing and precision fermentation with the goal of making affordable, high-value recombinant proteins, enzymes, and growth factors to help slash Africa’s biopharma import bill.
“One of the biggest things we realized as a country, but also as Africa, is that we’re importing 99% of our biologics and drugs. For the COVID-19 vaccine, we were the last group of people to get this vaccine,” he lamented. A cursory look at the South African Clinical Research Association, the equivalent of the FDA, shows they still follow the 2014 FDA guidelines, he said. “And that’s quite old,” he told GEN.
As a result, they would need to update their regulations to understand the science better, what biosimilars are, what mRNA vaccines are, and why the science is moving so fast that regulators are struggling to keep up.
Africa has “many opportunities” to domesticate its medical biologics supply chains, but reality is daunting, said Enslin, citing a recent “disruption” at Aspen—Africa’s largest generic drugs maker—which threatens an oral contraceptives shortage in South Africa.
Part of the reason is that GMP manufacturers of biosimilars, specifically, are far and few between on the African continent.
“In South Africa, we’ve only got a handful, and most of them are looking at small molecules, chemicals, and stuff like that, necessarily creating bio-biologics,” said Enslin.
The mission
The mission is clear for Immobazyme, which recently captured the limelight after raising $1.45 million in venture funding (bringing the total the company has raised to $2.9 million), which is modest by Silicon Valley standards but significant in South Africa’s limited venture finance ecosystem.
“Having our own GMP facility, manufacturing biosimilars for the African continent, that’s where we want to be by the end of the 2030s,” said Enslin, who is talking about “lower hanging fruit” for Africa’s biotech innovators to grab and accelerate through development and into the market.
He added that he is referring to “nutraceuticals, cosmetics, food and beverages, and agribiotech, which are subject to lower regulation and certification than drugs and other medicines. But it’s still the same premise that the African continent is struggling with these kinds of novel products.”
His first patent came about when he was a student at South Africa’s Stellenbosch University, the premier South African and African research corridor in the Western Cape Province, where billionaires live adjacent to bubbling ideas in biotech, banking, and software.
“We realize that these enzymes, whether it’s in an industrial application or mRNA manufacturing, are relatively expensive. And you use them once, and then you can’t recover them. You can’t reuse them again even though they’re perfectly fine to reuse,” he said.
So, they developed a method to immobilize enzymes on a solid metal matrix, allowing substrates to pass through and undergo enzymatic reactions while the enzymes remain in place for repeated use, he explains, giving an example of lactose-free myelin oligodendrocyte glycoprotein (MOG).
“What they do is they immobilize lactase, which is an enzyme that breaks it down into simpler sugars. And they passed the milk over and got lactose-free milk. But the current enzyme immobilization technologies that were out there at the time were either quite expensive or they weren’t optimized for multiple different kinds of applications. So, this is where PepTrap came in,” Enslin said, referring to the proprietary, synthetic cellulose-based enzyme immobilization technology developed by Immobazyme that traps and stabilizes enzymes, allowing them to be reused cost-effectively across multiple industries.
Getting the science right was the easier part for Enslin and his two co-founders. Scaling the science into any kind of business “is just really tough, but scaling a biotechnology company in South Africa is even tougher. It’s capex heavy. It’s infrastructure heavy. And then every time you 10x your manufacturing capability, you have to basically buy a completely new production pipeline to meet that scale,” he said.
The hub
For decades, South African universities have been excellent at generating world-class research papers, but much of that IP stays stuck in academic journals. LaunchLab CERIBIO is a 300 m2 biotechnology laboratory and business incubator at Stellenbosch University and looks to actively disrupt this “publish or perish” culture in South Africa. Enslin’s Immobazyme startup is one of the most successful spinouts from this incubator.
“It is very challenging to do commercial work in a university laboratory,” said Anita Nel, chief director of innovation and commercialization at Stellenbosch University. Hence, they have created this space to ensure that the university’s biotech spinout companies have a dedicated, shared space. They actively encourage their researchers to publish their results once CERIBIO has the opportunity to protect their inventions, as publications also bring credibility to their research. “It is more a case of patent before you publish than preventing publication at all,” she added.
When a university researcher comes to LaunchLab CERIBIO with a breakthrough, there is a filtering method to ensure the presentation can translate into commercial success. “We perform due diligence on every new invention that is disclosed to us to make very sure that there is commercial potential, that it is novel, and to determine what the best route to market is—either a license to a company with an existing market or a new spinout company with the support of the university,” she told GEN.
The spinouts from LaunchLab CERIBIO are also supported to de-risk the ventures further and are connected to both local and global investors who can provide funding to help them progress faster. “These investors understand the deep-tech and biotech space and feel comfortable investing in this sector, without expecting the fast progress that you typically see in fintech,” she added.
Nod of approval
Immobazyne’s recent venture financing success is a riposte to critics who for a long time have argued that Africa’s biotech can’t attract this kind of liquidity. It’s a massive nod of approval, Enslin explained. “I think that’s a testament to the kinds of companies that are coming out of the African continent and that resilience and the determination. There have been some amazing success stories coming out of South Africa,” he said, pointing to South Africa’s Kapa Biosystems, which was acquired for a record $445M by Roche in 2015.
“It’s an affirmation that we can actually build something incredible here. I think it’s heating the ecosystem here on the ground in the Western Cape specifically. I mean, they’re calling us the Silicon Valley or the Cape Silicon Valley,” he said with humor.
