Every year, all across the world, there is a fascinating process that takes place. People take sugar, feed it to yeast, and a few short days later, a product is extracted and enjoyed by millions. We commonly refer to this process as brewing beer. However, Christina Smolke and her company, Antheia, have taken this same process and applied it to a different industry – prescription drugs.

Instead of making beer, Antheia uses bioengineering to grow key ingredients for prescription drugs. The yeast they use is not the typical store-bought variety. It is a specially bioengineered yeast that has been meticulously researched and modified with genes from multiple species. This unique yeast has the ability to produce specialty chemicals in large quantities and at a much faster rate than conventional methods.

Recently, Antheia announced a significant achievement – their first commercial-scale fermentation run. This resulted in the production of 116,000 liters of thebaine, a crucial ingredient for multiple essential drugs. What is even more impressive is that Antheia accomplished this in just five days, whereas traditional methods would take several months. This milestone is a major step forward for the company, as they plan to bring their first products to market next year. These products will consist of key ingredients for drugs that are currently experiencing significant shortages.

According to a survey conducted by the American Society of Health System Pharmacists, shortages of essential medicines are forcing hospitals to ration or even cancel necessary medical interventions. This shortage not only affects patient care but also leads to an increase in the price of essential medications. Antheia aims to address this issue by focusing on producing key ingredients for drugs that are in short supply.

One such drug ingredient is injectable opioids, which are used for pain management. Traditionally, these opioids are grown in fields over the course of several months or years. However, relying on agriculture can lead to problems such as pests, storms, and interruptions in shipping. Antheia is developing a solution to this problem by bioengineering thebaine and oripavine, key components of pain and addiction management medications. They are also working on over 70 other ingredients for different types of drugs, including scopolamine used in anti-nausea and anti-spasm medications.

Christina Smolke, the cofounder and CEO of Antheia, believes that the current supply chains for these ingredients are inefficient and unsustainable in the long-term. She aims to utilize the versatility and scalability of biological systems to create more efficient production methods. Smolke’s inspiration comes from nature itself, as she believes that nature is the best chemist.

Smolke’s groundbreaking research on bioengineering yeast to produce hydrocodone made headlines in 2015. This research led her to cofound Antheia with the goal of scaling up production to meet the needs of the pharmaceutical industry. In order to achieve this, Antheia had to engineer the yeast itself by incorporating genes from the source plants of these drug ingredients, as well as genes from other organisms.

Antheia’s achievements in bioengineering and large-scale production of drug ingredients hold great promise for the pharmaceutical industry. By addressing drug shortages, they are not only improving patient care but also making essential medications more accessible and affordable. With their innovative approach, Antheia is revolutionizing the way we produce key ingredients for prescription drugs, taking inspiration from nature to create a more sustainable future.

Scaling up bioreactor processes for the production of drug ingredients can be a complex engineering challenge. While small bioreactors in the lab are relatively easy to fine-tune, industrial-scale production requires careful management of equipment, temperatures, and fermentation conditions.

Antheia, a synthetic biology company focused on making drug ingredients, recognized the need to develop techniques for commercial-scale production. In 2021, they partnered with an Italian biomanufacturer to tackle this challenge head-on. According to Kazi Helal, a biotech analyst for Pitchbook, Antheia is the only company specifically targeting this niche market.

The complexity of the pharmaceutical production process, with its numerous chemical steps and custom enzymes, makes scaling up even more difficult. However, Antheia remains undeterred, focusing on delivering essential medicines to pharmaceutical companies. If successful, this could pave the way for commercial success on a large scale.

An important milestone for Antheia was the successful production of a commercial-scale batch of thebaine, a proof point that their technology can scale and meet commercial metrics. Despite the market challenges, investors have shown confidence in the company, raising $120 million to date.

In 2021, Antheia also joined forces with Ginkgo Bioworks, a synthetic biology company specializing in custom enzymes. This partnership will enhance Antheia’s fermentation process and further support their goal of commercialization.

Before Antheia can introduce its products to the market, it must obtain regulatory approval from the FDA and other agencies. This entails demonstrating that the bioengineered yeast-produced drug ingredients meet the same quality standards as conventionally-produced ones. Antheia’s CEO, Christina Smolke, is optimistic and expects FDA approval by the end of the year, with the company officially entering the market in 2024.

Smolke envisions Antheia’s innovative approach leading to a transformation in the industry, making production more efficient, agile, and cost-effective. Through their efforts, they aim to revolutionize the drug ingredient manufacturing process and improve access to essential medicines worldwide.

In conclusion, Antheia is tackling the engineering challenges of scaling up bioreactor processes to produce drug ingredients. With partnerships, investments, and a focus on pharmaceutical companies, they aim to revolutionize the industry and provide a more efficient method of production.