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Ginkgo and Aldevron tout mRNA manufacturing ‘breakthrough’—and the perks could stretch well beyond COVID-19

August 13, 2021
Life sciences

A multibillion-dollar SPAC deal? Check. An international acquisition? Check. An mRNA vaccine production “breakthrough?” Ginkgo Bioworks says it has that, too.

With its latest manufacturing update, Ginkgo is angling to keep its messenger RNA insights relevant well beyond the pandemic.

After partnering with biomanufacturing expert Aldevron earlier this year, Ginkgo and its collaborator notched a win in the red-hot mRNA manufacturing field, the companies said early Tuesday. Specifically, they’ve worked out a way to boost production yields of the vaccinia capping enzyme (VCE), which is used to make mRNA vaccines and therapeutics. Ginkgo and Aldevron’s VCE manufacturing approach is more than 10 times more efficient than the prior process, the partners said in a release.

Following the mRNA advance, Aldevron is snagging exclusive rights to the protocol conditions of the new VCE process, the partners said. The development signals an “exciting milestone” for Ginkgo as it wades ever deeper into the pharma realm, CEO Jason Kelly said in a statement.

While much of the attention around pandemic supply shortages has focused on things like syringes and fermentation bags, Ginkgo chose to set its sights on molecular biology, Patrick Boyle, head of codebase at Ginkgo Bioworks, said in an interview. VCEs are in high demand thanks to their role in mRNA vaccine production, and they’re a component that Ginkgo figured it could focus on with its cell programming platform, Boyle said.

Ginkgo launched in 2009 with the goal to develop a platform that eases the cell engineering process. The company initially applied the platform to products such as pesticides and perfumes but has increasingly been exploring its approach in the pharmaceutical sector. Early last year, the company teamed up with Moderna to help the biotech with process optimization for raw materials used to make its mRNA vaccines. Elsewhere, Ginkgo is working with Roche to develop therapies against antibiotic-resistant bacteria.

Flipping back to mRNA, the challenge around VCEs, to hear Boyle tell it, is figuring out how to produce the component at unprecedented scales. Back at the start of 2020, there were “maybe about a hundred thousand people worldwide” who’d ever been dosed with mRNA, Boyle said. Now, Pfizer-BioNTech and Moderna are producing billions of doses.

In a nutshell, VCEs help the body recognize foreign mRNA. While a person’s body recognizes its own mRNA, mRNA delivered with a vaccine but without the cap would be seen as foreign and therefore be degraded. Essentially, the capping enzyme makes the shot “more human, such that it can be translated properly by your body,” Boyle said.

Under their partnership, the companies have been able to deliver a more than tenfold improvement in production output, measured in the amount of protein that’s recoverable from the entire process, Boyle said.

“If you were to grow this in a fermenter before and after the optimization, you get 10 times more product from our process,” he explained.

One of the challenges around mRNA vaccine production—and part of the reason manufacturing yields are so important—is that there’s “only so much fermentation capacity” available. If you can take a single raw material and get 10 times more of that product out of the same facility, manufacturers can lower costs and improve production timelines, Boyle said.

The most obvious application right now is for COVID-19 vaccines, but, “if we can continue to increase the scale and lower the cost of goods for making mRNA therapeutics writ large, there are lots of other opportunities beyond COVID as well,” Boyle said.

Aldevron already includes VCEs in its catalogue, so the Ginkgo team-up has primarily focused on improving manufacturing output, Boyle said. The partnership has the potential to address the entire mRNA market, and Ginkgo figures Aldevron already has a “sales channel” in place thanks to its relationships with vaccine producers like Moderna, he added.

For its part of the deal, Ginkgo helped provide “rapid prototyping,” Boyle said. The company’s bread-and-butter specialty is being able to “iterate through many hundreds of different genetic designs to try and develop an improvement,” he said. Aldevron, meanwhile, made sure that design translated well into manufacturing, he added.

It’s a common credo in the synthetic biology space that it’s tough to scale things. While it’s by no means easy, the partners’ work shows “when there’s an urgent need to scale something quickly, that two technology platforms like Ginkgo’s and Aldevron’s can get together and make that happen,” Boyle said.

by Fraiser Kansteiner

Source: fiercepharma.com

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