Thanks to $40m USD in financing from a number of investors, synthetic biology company Antheia is poised to make its plans for a pilot-scale manufacturing facility a reality. The 14,700-square-foot plant in Menlo Park, California, reportedly will enable the company to increase efficiency and scale up its portfolio of active pharmaceutical ingredients (APIs).
To learn more about the plant and the company’s plans for the short- and long-term future, Outsourcing-Pharma spoke with Antheia chief operating officer Zack McGahey.
OSP: Could you please share how things at Antheia have evolved in recent years—advancement of your technology, increased interest in your work, and growth, for example?
ZM: Antheia was founded to solve a problem familiar to pharma executives and physicians alike: the need to provide essential medicines when and where they are most needed. By the WHO’s estimates, over 2b people worldwide lack access to basic medicines, and even in the most advanced economies, medical shortages are a recurring reality. We saw this most dramatically during COVID-19 when medicines for patients on ventilators were in short supply.
Nearly half of pharmaceuticals are sourced from nature, which means the active pharmaceutical ingredients (APIs) we rely on are largely extracted from plants, farmed as crops. Relying on agricultural sources for these critical APIs requires years of growing and harvesting, all before even being able to extract the target molecule itself.
Additionally, raw sources are vulnerable to geopolitical and climate crises, so even if there is a successful harvest, the APIs may still not be usable or accessible. This results in fragile, unpredictable, and expensive pharma supply chains and regular drug shortages when the availability of raw materials is compromised.
The solution (in theory) is simple – ensure enough raw materials and you can ensure a consistent supply of essential medicines. In reality, there are a number of factors that make it increasingly difficult to secure a constant and reliable supply of raw materials.
Antheia is working to transform the pharmaceutical supply chain by leveraging the power of synthetic biology, so that essential medicines are no longer reliant on fragile supply chains or legacy manufacturing models. Our team has spent the last two decades studying how plants synthesize complex pharmaceutical compounds and developing technologies to reconstruct these complicated biosynthetic processes with brewer’s yeast.
Shifting the plant-based drug supply chain from farming to fermentation enables manufacturers to more consistently and reliably produce higher-quality compounds – in weeks instead of years, and with significant efficiency and sustainability benefits. Importantly, our technology also offers new potential for onshoring API manufacturing in the US.
In the last few years, we’ve seen a massive uptick in both our technical progress and in interest from partners and investors. We are actively working toward industrial-scale production and will be breaking ground on our own pilot-scale manufacturing plant later this year.
OSP: Related to that, please tell us about the conversations that led up to the decision to construct a pilot plant—what company needs and industry demands helped fuel the move?
ZM: All biotech companies can agree that there’s no path to scale up without adequate pilot plant capacity.
When it comes to biomanufacturing, pilot plants are an essential component of scaling, and high-quality pilot plant capacity is increasingly scarce in the U.S as biotechnology continues to flourish. Quality pilot scale operators are in high demand, and booking capacity in short time frames is very difficult as a result.
As we’ve continued to hit technical milestones and advance our entire pipeline of pharmaceutical candidates, it became clear that we needed to increase our own capabilities to maintain our agility and efficiency in bringing products to commercialization. Investing in our own on-site facility was a critical next step as we progressed toward commercial-scale production, specifically for optimizing strain performance and accelerating timelines.
Our team has developed and validated an alternative to conventional drug manufacturing technologies, and this pilot plant will accelerate our progress in scaling up multiple compounds in our pipeline. While there are great third-party CDMO partners, increased competition for their capacity makes them harder to come by – this plant will ensure we remain fully in control of our own scale-up timeline and offers opportunities for greater efficiencies.
OSP: Then, how will this new facility and added capacity help Antheia meet its future goals and meet industry demand better?
ZM: Our pilot plant will be able to run our fermentation-based products at 500L scale and will support the scale-up of several API candidates in our pipeline. By utilizing this facility, we anticipate two to four months of time savings per run, improved customer engagement through accelerated sampling and validation timelines, and increased utilization rates. It will also give us critical control of de-risking the path to commercial manufacturing, a stage of development that can be very challenging and expensive to navigate successfully.
Our synthetic biology platform can enable the production of a wide variety of plant-based APIs and our pipeline is closely aligned with the FDA Essential Medicines List and the Priority Areas listed by the ASPR. There is a tremendous opportunity for this technology to be used as a paradigm shift in how our essential medicines are made, and enabling a more efficient path to commercial scale with our products helps us recognize a more secure and reliable future for manufacturing of critical medicines in the US and globally.
OSP: Do you have anything to add?
ZM: We believe our technology can help advance the entire industry. Synthetic biology has the potential to change how we manufacture a wide variety of medicines, but to date, it has largely been used to produce biologics. Our work shows how synthetic biology can also make small molecule manufacturing more efficient and robust, and may lead to better production methods – whether measured by the speed of production, quality control, or even environmental impact – for a wide variety of drugs even beyond our current pipeline.
We are hopeful that our work will continue to drive innovation in the field and improve access to essential medicines on a global scale.