The US government is spending millions to prevent a shortage of glass vaccine vials

The type of glass needed to transport vaccines safely makes up just 10% of all glass production. So BARDA is giving manufacturing a kick-start.

This week, the US government’s Biomedical Advanced Research and Development Authority (BARDA) announced it would accelerate the race to distribute a Covid-19 vaccine by awarding millions of dollars for development.

Sound familiar? It should: In late April, BARDA announced a round of investments in the pharmaceutical companies that are developing the vaccines themselves; they’ve been adding to the list over time. But now, it’s announced a plan to make sure any proven vaccines can actually get to people: by kick-starting production of glass vials.

On Tuesday (June 9), BARDA awarded $204 million to the upstate New York-based company Corning to make glass vials needed to bottle and store vaccines. The money will help bring one of Corning’s New York factories to maximum capacity, and equip two others in New Jersey and North Carolina with the specialized hardware to do the same.

The goal is to ensure that once a vaccine makes it through all three stages of clinical testing, it can be widely distributed. This means ramping up glass production now to support clinical trials and other research, and eventually distribution. In early May, Rick Bright, then-head of BARDA, filed a 60-page whistleblowing complaint about the US federal government’s response to the Covid-19 pandemic, which in part warned of a looming glass shortage. (The Trump administration fired Bright shortly after.)

It might seem surprising that glass could be a significant bottleneck for vaccine distribution. But the type of glass needed to transport vaccines safely makes up just 10% of all the glass that companies produce. It’s more expensive, and requires specialized equipment to manufacture.

The majority of all glass is silicon dioxide—one part silicon, two parts oxygen. (Crystallized silicon dioxide is Quartz, our namesake mineral.) Added chemicals can change the glass’s characteristics; the glass in our kitchenware and windows, called soda-lime glass, includes sodium, calcium, aluminum, and magnesium. It’s cheap to make, but not the most chemically stable: Some of those molecules will leach out into the liquid, turning the glass foggy as liquid takes their place.

This chemical interaction happens at the molecular level, and there’s no danger to anyone eating out of glass containers, says Robert Schaut, the scientific director for Corning Pharmaceutical Technologies. But the chemical compounds in pharmaceuticals like vaccines cannot have any contamination—especially when their own makeup could speed up the leaching process.

This is where pharmaceutical glassware comes in. This class of glass, called borosilicate glass, has higher levels of aluminum and boron, which decrease the glass’s reactivity, making it safe to transport drugs.

The issue with borosilicate glass, sometimes, is that at high temperatures, some of the boron can dislodge from the glass and resettle somewhere else in the vial, eventually creating microscopic glass particles that flake off. The product inside gets contaminated again. Corning’s pharmaceutical glass, called Valor Glass, “was intentionally designed to have optimized properties—without boron,” says Schaut. It took years of tinkering to find a chemical composition that allowed essentially no reactivity at any temperature.

Borosilicate glass could work to hold new vaccines and drugs, but Valor glass is an improved version. Both require more technical equipment and know-how than run of the mill soda-lime glass. That’s why Bright and others have been worried about shortages.

The goal of the US Operation Warp Speed is to have 300 million Covid-19 vaccines ready by January. The hope is that, with $204 million in funding, Corning will be able to support the pharmaceutical companies that BARDA has already partnered with, including Moderna, Johnson & Johnson, and AstraZeneca. Which vaccine its vials will be holding is still unclear, although Moderna, a Cambridge-based biotech startup, announced this week that it would be starting a 30,000 phase 3 clinical trial, next month.

Once there’s a vaccine and the vials to transport the doses in, doctors will need enough supplies on hand to administer millions of shots. On Monday, BARDA awarded a $143 million to SiO2 Materials Science in Auburn, Alabama to expand its syringe production.  The Company will add 200 High Skilled Manufacturing Jobs.

SiO2 Materials Science, a privately-owned U.S. advanced materials science corporation introducing breakthrough disruptive technology for packaging biological pharmaceuticals and vaccines, today announced a $143 million agreement with the federal government. The agreement with the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) in partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), accelerates the production scale-up of the company’s state-of-the-art, patented, primary packaging platform for storing novel coronavirus (SARS-CoV-2) vaccines and therapeutics.

SiO2’s syringes are precision molded and up to 15 times more dimensionally consistent than glass, enabling error-free operation with autoinjectors and other drug delivery devices.

SiO2’s patented materials science was developed in Auburn, Alabama over 10 years with the assistance of experts from four major U.S. research institutions, University of California, Santa Barbara and Berkeley, University of Chicago, MIT, and Harvard, and included the participation of Dr. Glenn Fredrickson, one of the most prominent material scientists in the United States.

“The SiO2 vials solve significant challenges in the commercialization of vaccines and biological drugs, which presently cannot be solved by glass or plastic vials,” Fredrickson said. “Bringing this advanced coating to market will enable pharmaceutical manufacturers to safely and more rapidly deploy their critical products.”

SiO2 currently employs more than 200 engineers, scientists, and technicians, most of whom live in Lee County, Alabama and are Auburn University graduates, in a 165,000 square foot manufacturing plant in Auburn. The company expects to hire 200 more.

About SiO2 Materials Science:

Managed by the same family for more than 100 years, SiO2 Materials Science is a privately owned U.S. advanced materials science corporation introducing breakthrough disruptive technology. The company is located in Auburn, Alabama. The company has deep partnerships with leading professors at the foremost research universities such as University of California, University of Chicago, MIT, and CalTech. For more information, visit www.sio2ms.com.

 

 

 

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