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The Medicine Cabinet Of The Future: If You Can Imagine A Drug, This Company Can Make It

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I have previously written how big pharma has been slow to innovate and adopt the latest synthetic biology tools, which could vastly speed the creation of new treatments and vaccines. 

I’m changing my mind. 

Last week, on the heels of SynBioBeta 2019, Codexis held its annual Protein Engineering Forum in Palo Alto, California. The forum brought together leading scientists and engineers to share the latest in protein engineering, which is being revolutionized by the tools of synthetic biology. The forum aimed to see where science is taking proteins, and what proteins can offer the world.

Codexis CEO John Nicols opened the two-day forum by remarking on the extraordinary success protein engineering has had in bringing real-world applications to market faster and more often, and the hope that the meeting would represent another milestone in the progress of proteins.

It certainly seemed to be. Here are a few examples of how biopharma is making the jump to lightspeed:

Accelerating evolution to make drugs with biology: I recently wrote about Nobel Laureate Frances Arnold’s pioneering principles for nudging nature to do what she does best: evolve. Merck has taken this to heart by using her directed evolution methods to go from chemistry-based to biology-based production of its diabetes drug, Januvia. The result: an efficient, economical, and environmentally friendly process for manufacturing a range of drugs.

Unleashing computers: To respond to a wider range of more complex diseases, companies like Amgen are making their R&D pipeline more flexible and higher volume. To do this, they are integrating the latest in computation and experimental methods. This promises to speed the development of protein therapeutics, which can replace abnormal or deficient proteins in diseases like arthritis, cardiovascular disease, and blood disorders.

Cascade reactions: The ability to engineer extremely effective enzymes — the proteins that catalyze chemical transformations — allows biologists to put many steps in a single pot, going from starting materials to finished product in one go. This makes the process more sustainable and more efficient; to paraphrase one participant, “If it’s sustainable, it’s also cheaper.” Researchers at biopharma giant GSK reported that most of their projects are going in this direction. GSK’s commitment to the environment is reflected in giving projects an environmental score — and cascade reactions are a green dream.

The DNA to build it all: Using the power of silicon to write the DNA needed for just about any biopharma application, CEO Emily Leproust described how her company helped researchers develop a rapid response tool to make antibodies to fight global viral threats like Zika and Ebola. The company also spun out Twist Biopharma with an emphasis on creating new antibody drugs for difficult-to-target diseases.

The protein revolution isn’t limited to biopharma, either. Here are a few other areas highlighted at the forum where protein design is having big impacts:

Cannabinoids: I’ve previously written about the benefits of brewing cannabinoids as you would beer, such as producing rare cannabinoids not easily purified from plants. Companies like Invizyne are going one step further by taking biology pathways out of cells and into cell-free systems. Invizyne is just one player in a field of heavy-hitters pursuing cannabinoids, including Amyris, Ginkgo Bioworks, and Intrexon.

Bioplastics: There’s a buzz about bioplastics. Protein engineers are evolving enzymes to break down plastic in the environment. Conversely, they can — and have — created bioplastics from biological sources, ones that are more biodegradable than their petrochemical cousins. 

Biofuels: In the earliest days of synthetic biology, pioneers like Jay Keasling went after biofuels. As a commodity chemical, this was a very challenging first target: it’s a commodity chemical that must be produced on a tremendous scale, and compete economically with the petrochemical industry. (That’s why much of the industry retreated to higher-value chemicals from the “top of the barrel.”) Fast-forward to 2019: James Liao, Keasling, and other researchers have tools to radically change the way we ferment ethanol and other fossil fuel replacements, hinting at the new golden age of biofuels to come.

What does this mean for manufacturing?

The science and technology we use to make proteins are going to transform manufacturing, but how? Will manufacturing continue to require central manufacturing facilities with their high capital equipment costs? Or are markets going to benefit from faster, cheaper, and better ways of making chemicals and materials?

“We think about this all the time,” said one participant. “We see a day when, instead of large, expensive manufacturing facilities, you will have your entire biomanufacturing platform on a skid. Add glucose and your enzyme cocktail, and it will produce your final product, maybe even in pill form. You could pick it up, put it on a plane, send it anywhere in the world that it’s needed.”

Where do big data and AI fit in?

Industry has invested billions in R&D to bring products to the market. In doing so, it has accumulated enormous amounts of data. Much of that data is about failed attempts, such as drug candidates that fail in the late stages of clinical testing. Companies tend to share info about successes, but not about failures. So all that data remains locked in company databases, waiting for the day we can learn from it with computer algorithms and other sources of big data. 

How can we encourage companies to share with the rest of the world? Can the government play a role in providing sharing incentives? If companies could find good ways to share that information, with the right incentives for everyone involved, it would open up a huge range of new possibilities for the industry. Maybe advanced encryption techniques could allow companies to share some data and conceal others.

What does it all mean for you and me?

Some of us are already benefiting from advances in protein science, such as the diabetes medicine Januvia I mentioned above, where the same product is now made with reduced pollution and waste. But for others, the revolution in protein engineering is shortening the time it takes to take a drug from bench to bedside. 

At the Codexis forum, there was a confidence on the part of the biopharma participants that synthetic biology tools and technologies will soon be able to make just about any drug or vaccine you can think of. As one participant put it, “When we’re asked, ‘Do you have an enzyme that can make that?’, the answer isn’t ‘yes’ or ‘no.’ The answer is ‘yes’ or ‘not yet.’”  

In the future, we can expect entirely new products. For example, an engineered probiotic is now available to prevent hangovers

Perhaps the most important area is the one we can all relate to the most: human disease. Gjalt Huisman, Senior VP of Strategic Development at Codexis, has spent most of his career in biotherapeutics, and he shared an experience he had at a conference on phenylketonuria — a rare but potentially devastating disease.

“I was speaking at a conference with patients and their family members in the audience, as well as scientists,” Huisman said. “After our session, this older man came up to me and said, simply, ‘My granddaughter has PKU, and we count on you.’ It was a revelation to me, and a reminder of the big job we have ahead of us in the real world.”

With a little courage and the right tools, biopharma is poised to make me a believer. 

Acknowledgment: Thank you to Kevin Costa for additional research and reporting in this post.

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