rBIO launched last week with technology that can reduce the cost of insulin by 30 percent, making U.S. manufacturing cost-effective for insulin and several other drugs.
This new method is an enhancement of the recombinant DNA (rDNA) processes that have been used since the 1980s to produce insulin.
“Forty years later, we’re taking it to the next level,” Cameron Owen, rBIO co-founder and CEO, told BioSpace. It is akin to expediting billions of years of evolution.
The company genetically modified E. coli to cause it to hyper-produce peptide hormones – initially, insulin – thereby creating more product from the same quantity of material. Those bacteria will then manufacture the product at scale using standard vat fermentation processes.
The idea emerged when Owen was a graduate student at Johns Hopkins University’s Carey Business School.
“I had started another biotech company (Aevus Precision Diagnostics) that looked at the pharmacogenomics of diabetes medications, so I got to know the diabetes space really well,” he said.
As he learned, “Insulin is too expensive for many people who depend on it, and its supply chain is vulnerable because – like most drugs used in the U.S. – a large percentage of insulin is manufactured offshore. With 30 million diabetics in the U.S. now, and an expected 60 million by 2030, keeping up with demand is a significant challenge.”
In 2016, the J. Craig Venter Institute determined the minimum number of genes bacteria needed to survive.
“If you can take those minimal genes and add to them, you’ve eliminated a lot of processing waste,” Owen said.
Therefore, rBIO is rewriting E.coli’s genetic code, eliminating the unnecessary genes and coding the genome so the bacteria hyper-expresses the maximum quantities of insulin but does not produce the products needed for the bacteria’s normal metabolic function.
rBIO’s goal is to increase production to the cell’s theoretical limits. In this case, that’s 100 molecules of insulin.
“We haven’t achieved 100% theoretical maximum yield,” he said, but production rates are approximately double that of today’s generally accepted insulin production methods.
What’s different about this approach, beyond its high yield, is how the genetic code as devised. “We’re now at the point in genetics where the genetic code can be not only manipulated, but written,” Owen said.
Rather than cut and paste genes in or out of organisms, rBIO actually designs the DNA, he said.
“We’re writing the DNA code from scratch, the way a computer programmer would, and translate it to biology,” he said. “Rather than use ones and zeros, we use ACGT – the bases found in DNA molecules. We can manipulate those letters to write anything you want.”
The rBIO team doesn’t start entirely from scratch, of course. “There are set sequences that we know work, so we are using those sequences,” and designing others, Owen said. “We wrote three different genetic codes for the bacteria during the past several months and put them into a lab setting to determine if they first and foremost grew and divided, and secondly whether they produced the product we wanted.”
Two of the three bacteria strains were successful, and optimization is continuing.
Once rBIO determines the genetic code it wants, it outsources the actual gene assembly. rBIO has produced several milligrams of insulin this way in the lab.
The next stage, Owen said, is to scale up the company. That means bringing in management with the skills to take the organization to the next level and to help shape its direction.
This early in its existence, all the options are open.
“My goal is to become a manufacturer,” Owen said, “but, realistically, this is more of an out-licensing opportunity to a company with the existing infrastructure for mass manufacturing already in place.”
rBIO is still developing a platform technology, Owen pointed out. The company is focused on insulin, but also is considering eight other drugs for its pipeline, including erythropoietin and epinephrine. “They each have a projected compound annual growth rate (CAGR) of 12 percent for the next decade,” he said, so represent significant opportunities for the company.
Owen said the company’s technology also has the potential to make reshoring attractive for several drugs that currently are produced offshore.
The COVID-19 pandemic put the spotlight on the risks of off-shoring pharmaceutical products. According to the FDA, only 21% of the drugs on the World Health Organization’s Essential Medicines List are manufactured in the U.S.
Medicine security shouldn’t be allowed to be affected by the fluctuations of international trade policies, he said. “Having the manufacture of life-saving medicines offshore is a major national security issue. Imagine what would happen if 30 million American diabetics couldn’t access insulin. We’d be in a world of hurt.”
Whether or not such drastic trade wars happen, rBIO’s hyperproduction technology may offer significant benefits to therapeutic manufacturers and customers alike. He isn’t overly concerned about competition. Instead, he sees potential allies.
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