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How scarcity of niche biotech ingredients has slowed Covid-19 vaccine production

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Acuitas Therapeutics, a tiny biotechnology firm in Vancouver, B.C., has just 30 employees and leases its labs from the University of British Columbia. The company doesn’t even have a sign on its building. Until last year, it outsourced production of only small volumes of lipid nanoparticles, fat droplets used to deliver RNA into cells, for research and a single approved treatment for a rare disease.

But now, one of Acuitas’s discoveries has become a precious commodity. A proprietary molecule called an ionizable cationic lipid is a crucial piece of the mRNA vaccine made by Pfizer and its German partner BioNTech, and it is in urgent demand for production of billions of vaccine doses worldwide.

Scaling up production of formerly niche substances such as lipid nanoparticles for a global vaccine drive has been among the most complex challenges facing the Biden administration as it aims to ramp up the frustratingly slow provision of shots across the country, according to interviews with company officials and outside scientists and government reports.

On Jan. 21, the new president’s second day in office, the Biden administration issued a report that cited shortages of lipid nanoparticles among “urgent gaps” in the vaccine supply chain.

It’s on a scale that hasn’t been done before,” said Pieter Cullis, the Canadian scientist and Acuitas chairman who is considered a godfather of lipid nanoparticle technology.

Although companies are steadily increasing the flow of vaccine doses to states, deliveries have seriously lagged behind earlier government projections. The production problems — which the companies have declined to discuss in any detail — underlie the difficulty of the quest for vaccine shots by elderly U.S. residents in states that have prioritized this population for immunization. ...

Many other bottlenecks have plagued the manufacturing of vaccines for the novel coronavirus, which causes covid-19. Companies have had to build equipment from scratch, including machines that shoot two streams of solution — one containing mRNA and one containing lipids — into a high-speed collision to fuse the nanoparticles and encapsulate the genetic payload. ...

 

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