By Vivienne Raper
Brewer’s yeast engineered with synthetic biology to produce drugs or raw materials could transform pharmaceutical supply chains. That’s according to Christina Smolke, PhD, CEO and co-founder of Antheia.
Smolke, who will be speaking at SynBioBeta 2023, says that using engineered yeast to produce active pharmaceutical ingredients (APIs) in a fermenter could reduce drug shortages by relying less on ingredients sourced from plants, animals, and other organisms.
“When you look at many of our essential medicines today, and the active ingredients that are required to produce them, a substantial fraction are still being sourced from nature,” says Smolke.
“That’s very inefficient, and the cycle for manufacturing can take years just because of the time involved in growing the organisms.”
According to Smolke, examples of critical ingredients sourced from nature include chemotherapy drug Taxol® from Pacific yew tree bark and Narcan as an intermediate derivative of the opium poppy.
Ingredients sourced from nature have inflexible manufacturing processes and can result in drug shortages, she explains, as some organisms can require several years to grow and be shipped to manufacturing sites.
To get around this problem, Antheia is modifying yeast to produce APIs, Smolke says. The yeast is grown on sugar in a fermenter, which means it can produce a batch of purified product in weeks, she explains.
According to Smolke, the company already has around 70 active ingredients in its pipeline, covering medical areas ranging from neurology to oncology, and are moving its first products into full-scale production this year.
The manufacturing process, she says, is reproducible and has been run at a scale of up to 1,000 L so far.
Going forward, Smolke hopes synthetic biology will have as big an impact on pharmaceutical supply chains as recombinant DNA technology.
“When recombinant DNA technology was introduced, one of the first applications in the pharma space was in switching over to recombinant biosynthetic insulin,” she says, explaining that—before that point—insulin was extracted from animals and had supply chain challenges.
Once the recombinant DNA technology was demonstrated, she says, “There was a wave of change right across the pharmaceutical industry, in terms of adopting this new more efficient technology, but it also had an impact on how new [future] medicines were made.”