Business & Investment

The vaccine revolution is coming in a small bubble of fat

If the messenger RNA vaccine is a pandemic breakout drug, the small lipid spheres that bring them into people’s cells are unsung heroes.

The world desperately needs more of both.


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Consider BioNTech, which bought only a few grams of fat at a time until a year ago. This is to support drug development programs that most people thought would take years to become mainstream. Currently, we are using major German chemical companies such as Merck KGaA and Evonik Industries AG to significantly expand the production of materials. This is an important step for Pfizer and its partner Pfizer to successfully plan to ship 2 billion Covid-19 vaccines this year. ..

“We need kilos and kilos,” said Sierk Poetting, Chief Financial Officer at BioNTech, citing lipids as one of the most pressing needs.

Producers are benefiting. On Thursday, Merck forecasts record revenues this year, demonstrating a surge in demand for lipid-producing units for vaccine developers.

Pfizer-BioNTech and Moderna Inc. Lipids have risen to the top of the global healthcare priority list because powerful vaccines from CureVac NV and other vaccines still being developed by CureVac NV and Sanofi cannot work without them. Messenger RNA, the genetic material at the heart of these vaccines, allows four different types of fatty substances (collectively, lipid nanoparticles) to move successfully from the factory to the human arm and enter the interior. Requires a protective shell consisting of (called). Of human cells.

Authorities are learning that increasing lipids is not so easy, as the government is considering supercharging the production of Covid vaccines.

“This is a very complex process,” said Joe Biden, who visited the Michigan plant last month with Pfizer CEO Albert Bourla, on lipids at the facility as part of the promotion of the double vaccine. A product that has vowed to produce with mRNA. Biden marveled at the close collaboration of mechanical engineers, chemists and biologists who “pioneered technology that was nothing more than theory and aspiration in less than a year.”

For Bob Langer, those aspirations go a long way back. As early as the 1970s, he sought to prove that large and complex molecules such as DNA and RNA could be captured and transported in smaller particles without destroying them.

“Everyone told me it wasn’t possible,” he recalled in a telephone interview. “The first nine grants were rejected. I couldn’t get a job as a faculty member.”

It turned out to be possible, and Langer hadn’t lost his job for a long time. Currently, the professor has a chemical engineering laboratory bearing his name at the Massachusetts Institute of Technology, focusing on the intersection of biotechnology and materials science. After decades of development, Langer co-founded Moderna in 2010 and is still on the board of directors. The company, like BioNTech and CureVac, is developing mRNA vaccines for infectious diseases as well as Covid, along with treatments for cancer and rare diseases.

“I don’t think people understand how important a delivery system is for all kinds of medicines,” Langer said. “The more complex drugs we have, such as RNA and DNA, the more work we have to do in our delivery systems and the more problems we have to solve. Lipid nanoparticles will be a big part of our weapons.”

First RNA therapy

The drug delivery sector entered the watershed moment in 2018 when the US Food and Drug Administration approved a new treatment from Alnylam Pharmaceuticals Inc. The drug, Onpattro, treats rare genetic disorders that cause nerve and heart damage. It works slightly differently from mRNA therapy, but is delivered via lipid nanoparticles. This meant that regulators had at least some comfort in the pre-pandemic concept.

Thomas Madden has worked with Alnilam for years to develop these pioneering lipids. But by the time he got approval, he had refocused on Vancouver-based company Acuitas Therapeutics in the area of ​​more promising mRNA. He recalled the moment of Eureka around 2011 when he read a scientific treatise detailing recent advances in the field and concluded that companies still need better tools for distribution. This is because the body is flooded with enzymes designed to instantly cleave mRNA that has been found to circulate outside the cell.

To prevent that, Covid Shot’s mRNA is inside a shell made up of four lipids. After protecting the mRNA during its transfer to the human arm, the nanoparticles are taken up by the cell. There, positively charged lipids help the mRNA escape. Once in the cytoplasm of the cell, the mRNA directs the cell to make a copy of the coronavirus peplomer protein, inducing the body’s immune system to build a defense.

Moderna has designed its own charged lipids, and Acuitas has licensed its delivery technology to BioNTech and CureVac. Each of these companies was engaged in early clinical trials of mRNA treatment prior to the pandemic.

When Covid-19 emerged, Madden flew to Germany and told regulators and BioNTech officials how to start clinical trials of mRNA Covid shots most quickly. They decided to reuse lipid nanoparticles from the rabies vaccine developed by CureVac. Because it has already proven to be effective for people.

“The package doesn’t care what’s inside,” Madden explains. “It’s just going to deliver it.”

More dose

In addition to the planned doses of 2 billion from Pfizer and BioNTech, Moderna aims to produce 1 billion shots, and CureVac aims for an additional 300 million shots. These and other companies are also moving rapidly to develop other mRNA products in their pipelines, increasing the unprecedented demand for lipid nanoparticles.

Major pharmaceutical companies and chemical manufacturers are paying attention. In early February, Germany’s Merck agreed to speed up the supply of lipids to BioNTech, followed by Evonik a week later.

Evonik is diverting tanks and containers at two plants in Germany to purchase new equipment for the purification process.

“This process typically takes a year or two in the pharmaceutical industry,” said Thomas Riermeier, head of the company’s healthcare division, in a video interview. “What we need to do here is to do this more or less in a couple of months.”

© 2021 Bloomberg

The vaccine revolution is coming in a small bubble of fat The vaccine revolution is coming in a small bubble of fat

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