SA biotech company Afrigen Biologics has signed an agreement with Belgian firm Bio-Sourcing to manufacture medicines in the milk of genetically engineered goats — a move aimed at providing African patients with more affordable treatments for diseases ranging from cancer to diabetes.
Medicines made in living organisms such as white blood cells or enzymes are known as biopharmaceuticals and include products such as monoclonal antibodies and insulin.
Conventional biopharmaceutical production uses stainless steel bioreactors but there is growing interest in using genetically engineered animals to do the job more cheaply. Afrigen and Bio-Sourcing have agreed to set up a joint venture that will establish a pilot plant to manufacture biopharmaceuticals in Cape Town, for patients on the African continent, said Afrigen CEO Petro Terblanche.
There are currently no biopharmaceutical manufacturers in SA and imports are so expensive that they are available to only a fraction of the patients who could benefit from them, she said.
One of the most highly publicised, expensive biologic medicines is Roche’s trastuzumab, branded Herceptin, used to treat a subset of breast cancers. Despite the fact a cheaper copy of the drug called Herclon is now available, it remains so pricey that only some provincial health departments provide it.
The partnership not only has the potential to expand access to treatment by offering patients cheaper medicines but also offers hope of reducing Africa’s reliance on imports, said Terblanche. Africa’s limited capacity to produce its own pharmaceuticals was thrown into sharp relief during the coronavirus pandemic as African nations faced extensive delays in obtaining Covid-19 vaccines when shots were in short supply.
The venture will include full technology transfer to Afrigen and is expected to enable end-to-end manufacturing, from drug substance through to final product, said Terblanche.
We will cut our teeth on products with a clear route to market, but ultimately we will be looking at novel products with unmet needs.
— Afrigen CEO Petro Terblanche
“We will cut our teeth on products with a clear route to market, but ultimately we will be looking at novel products with unmet needs,” she said.
“Bio-Sourcing’s BioMilk platform ideally complements the state-of-the-art mRNA technology platform at Afrigen,” she said, referring to Afrigen’s mRNA vaccine manufacturing capacity. Afrigen made Africa’s first mRNA Covid-19 vaccine, using publicly available information about Moderna’s shot, and is a World Health Organisation hub for mRNA vaccine technology transfer to other African countries.
Bio-Sourcing invented the technology that underpins its biotherapeutic platform BioMilk, which uses genetically engineered goats to express human proteins — such as monoclonal antibodies — in their milk. The cost of biologics made this way is much lower those manufactured with conventional technology because it requires significantly lower upfront capital investment and produces higher yields, said Bio-Sourcing CEO Bertrand Mérot.
Establishing a transgenic goat farm with between 200 and 300 animals would cost between $10m and $15m, compared to the $500m to $1bn upfront investment required for a bioreactor for conventional biologic production, he said.
Bio-Sourcing and Afrigen have yet to finalise which medicines they will manufacture but are considering biosimilars, which are copies of off-patent biologics, to treat breast cancer and diabetes, he said.
The technology requires less water and electricity than conventional biologic production, is environmentally sustainable and well suited to countries in the global South, he said.
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