VIENNA—A key ingredient in what could be the first U.S.-approved Covid-19 vaccine comes from a family-owned company with 90 employees in the Austrian countryside, underscoring the fragility of the potential treatment’s supply chain.
Polymun Scientific Immunbiologische Forschung GmbH is one of a handful of makers of lipid nanoparticles, microscopic vessels used to deliver genetic material into the body.
For years, this was a niche application, used to deliver new forms of cancer treatment, for instance. Then came the coronavirus pandemic.
Lipid nanoparticles are required in the manufacture of so-called mRNA vaccines, including the one developed by
that is currently being tested in humans and is a front-runner in the global race for a Covid-19 shot.
Such vaccines are made of genetic material that needs to be protected by a lipid nanoparticle before it can be injected into patients. This means a product few outside the most advanced fields of medical research had heard about until recently is now in high and urgent demand—similar to other parts of vaccine and virus-testing supply chains, from refrigeration equipment to certain chemicals and medical-grade glass.
In September, Pfizer Chief Executive Albert Bourla and BioNTech counterpart Ugur Sahin used the American company’s executive jet to travel to Polymun’s headquarters in Klosterneuburg, Austria, whose spires and domes overlook the river Danube, and reassure themselves that their partner would meet its production targets, according to representatives of the companies.
The partners expect to submit their jab for authorization in the U.S. and Europe in November and bring it to market before the end of the year, pending successful final-stage clinical trials and authorization. Governments around the world have preordered nearly 500 million doses of the vaccine, meaning delivery would be staggered over many months once the product is approved.
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Among the many constraints on producing vast quantities of the vaccine at high speed is Polymun’s limited ability to scale up production.
One reason is that the technology used by the company is both complex and niche, which makes it hard to find qualified staff to handle it and time consuming to train people with adjacent expertise, said Polymun CEO Dietmar Katinger.
“It’s like retraining metal workers to process wood—the principle might appear similar but the shift takes its time,” Mr. Katinger said. “It is a new technology that very few people have been involved with so far.”
The company, which hires mainly graduates from the region, is so reliant on its scientists’ highly specialized skills that it suffered a minor disturbance recently when three employees applied for parental leave, Mr. Katinger said.
One way Polymun has tried to increase production is by sharing some of its know-how with Pfizer. Polymun employees are now overseeing an effort by the pharmaceutical giant to manufacture the lipid nanoparticles in house. A Pfizer spokesperson said that the process was being set up in Pfizer’s factories both in Europe and the U.S. to secure the supply chain for the vaccine.
“This is a common practice during tech transfer, and highly valuable,” the spokesperson said.
For shipping, Polymun relies on a specialized carrier—another potential bottleneck in the supply chain—that ferries its products in refrigerated trucks to the Pfizer factory in Puur, Belgium, from which finished doses are distributed globally.
Prof. Luigi Battaglia of the University of Turin in Italy said that there has been extensive academic research into lipid nanoparticles but very few companies produce them commercially because gene-based treatments are an emerging field of pharmacology and aren’t yet in widespread use.
With the pandemic abruptly reordering priorities in the medical field, small companies such as Polymun and BioNTech have been thrown into the spotlight.
Founded in 1992 by Mr. Katinger’s father, Polymun has limited direct competition—the other two key companies in the field are Acuitas Therapeutics in Canada and Avanti Polar Lipids Inc. in the U.S. Because of that, Polymun now works for several companies and institutions developing Covid-19 jabs, including U.S. firm Arcturus Therapeutics Inc., Germany’s
and Imperial College London.
which is also developing an mRNA vaccine, is producing its lipid nanoparticles in-house.
“Up until recently, the few companies focusing on LNP production could meet the demand of mRNA delivery companies, but the unanticipated high demand for LNP production in the pandemic is very likely to delay some companies, and put them in the queue,” said Nenad Svrzikapa, a researcher with the University of Oxford specializing in oligonucleotide therapeutics, which include mRNA platforms.
Hermann Katinger, Polymun’s 80-year-old founder, stepped down as CEO in 2009, handing the reins to his son. Both have refused to sell or go public and only very few employees have ever left after joining, Mr. Katinger said.
Andreas Wagner, who has been the company’s chief scientist since 2001, developed what would become one of its key manufacturing processes for his doctoral dissertation, a project that was itself funded by Polymun.
But Mr. Katinger doesn’t see the company’s diminutive stature and tightknit team as weaknesses. On the contrary: The choir singer who wears Birkenstocks at work says Polymun’s scale and cohesive staff make it innovative and unbureaucratic—both valuable traits in a pandemic that is stress testing swaths of the medical and pharmaceutical fields.
“In the pandemic the requirements are ideas and innovation,” he said.
—Jared Hopkins contributed to this article.
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