CORNING, N.Y.—Near the back of a Corning Inc. glassmaking plant here, a robot picked up a cage packed with hundreds of tiny vials and plunged it into a salt bath bubbling at more than 500 degrees Fahrenheit. The hot soak for several hours is a key step in fortifying the glass vials from cracks, flakes and breaks that could thwart global efforts to stop the coronavirus.
Drugmakers and health authorities are counting on Corning’s new medical glass container, named Valor, to protect Covid-19 vaccines better than conventional ones, especially during initial months when supplies will be limited and little can afford to be lost.
Thanks to their special recipe, Valor vials can be filled faster than conventional counterparts, and then withstand the subzero temperatures required to store the leading vaccine candidates. The vials are also embedded with identifiers visible under black light to prevent counterfeiting.
Corning’s Valor Tries to Rescue Glass
In 2017, Corning unveiled Valor Glass, a new formula to be used for vials that hold vaccines and other pharmaceutical products. The product is designed to be stronger and less likely to crack than conventional medical glass, known as borosilicate glass. Corning also applies a protective coating that allows drugmakers to fill vials faster.
Most important for protecting the precious cargo, however, is Corning makes the glass harder to break or crack than standard versions. “We’ve made it super strong,” Chief Executive Wendell Weeks said in an interview.
Valor glass vials were approved for use by federal health authorities just a few months before the new coronavirus hit. Since then, demand for the containers has surged so much the glassmaker has bolstered manufacturing to churn out tens of millions a month.
Analysts expect the product will help the company offset slowing businesses and furnish sales growth.
Yet Corning faces the difficult task of scaling up a new product much faster than it normally would. Making Valor is also more expensive and takes longer than conventional glass because of steps like the hot salt bath.
“The question is whether they can make enough vials soon enough,” said Anna Nagurney, a professor at University of Massachusetts Amherst who studies supply-chain logistics.
Covid-19 vaccines will be crucial to disarming the virus and allowing life to return to normal. Yet immunizing much of the world’s eight billion people requires so many vials—hundreds of millions—that medical glass has fallen into shortage. In addition to using conventional glass models, vaccine makers are turning to other types, such as ones made with plastic.
Vials must satisfy a range of specifications, from withstanding jostling during shipping to resisting temperature changes and keeping contents stable. Conventional pharmaceutical glass hasn’t always been up to the task. Breakage has been a persistent but little-noticed problem for the drug industry, scientists say.
Medicines can’t be used after a vial cracks. Fragments can harm patients. Even microscopic scratches can affect a drug’s chemistry and how it works. A fifth of recalls of sterile-injectable drugs from 2008 to 2012 stemmed from the presence of glass particles and dust shed by their vials, according to a 2014 Journal of Pharmacovigilance article.
“The idea of making a vial where you don’t have all these issues is very tempting to a company like Corning,” said Mario Affatigato, a professor of physics at Coe College. “They live off of innovation in glass.”
The company, founded in 1851, pioneered many new kinds of glass, including Pyrex, which can sustain high heat in cooking, and the first fiber optical cable that led to technology for transmitting high-speed internet.
Corning stopped making medical glass vials in the 1980s. Mr. Weeks recognized the opportunity in the market while hearing talk of broken and damaged vials as a board member of drugmaker Merck & Co.
“The glass composition hadn’t changed in a hundred years, and the package really hadn’t changed much in 50 years,” said Mr. Weeks, who left Merck’s board this year after 17 years.
In 2011, Mr. Weeks told his top scientists to redesign medical glass “from the ground up.”
Company scientists traveled to Merck and Pfizer Inc. to learn how the drugmakers used vials and why they incur damage during manufacturing and distribution, the companies say.
The researchers performed thousands of experiments replicating breakage, and melted about 500 glass concoctions searching for a formula that didn’t break as much, said Rob Schaut, a glass scientist and Valor co-inventor.
Their conclusion: change the glass formula to swap in aluminum for the element boron that researchers found to be responsible for flaking, just like the company had done to make its strong glass used in iPhone screens, Dr. Schaut said. Corning also tweaked other chemical properties.
Once the pharmaceutical glass is formed into vials, Corning leaves them in the salt bath for about eight hours, triggering a chemical reaction that strengthens the glass. Corning’s glass used in the Apple Inc. phones, called Gorilla Glass, undergoes the same process. Corning also coats Valor vials with a super-thin clear material to improve damage resistance and reduce particle generation.
Valor vials are at least 40 times less likely to break than conventional glass containers made with boron that didn’t receive chemical strengthening, Corning said its testing found.
In 2017, Corning rolled out Valor, and last year the Food and Drug Administration approved the first product using the vials.
In June, Corning signed a $204 million contract with the U.S. government to fund expanded manufacturing capacity to make an additional 164 million vials annually.
Corning upgraded machines and hired 100 workers. To expand production, the company is opening a new manufacturing plant in Durham, N.C., ahead of schedule.
At least three vaccine makers are using Valor vials, though Corning declined to name them.
Pfizer announced a contract for Valor vials in May, though a Pfizer spokeswoman said it is evaluating whether to use them for its Covid-19 vaccine, which must be stored at ultracold temperatures. The dollar value of the contract wasn’t disclosed.
Analysts estimate Valor’s price to be higher than standard vials, which cost less than $1 apiece. Corning declined to specify its price.
Ronald Verkleeren, who oversees Corning’s life sciences division, said it expects Valor sales to surpass $100 million by 2023 and generate at least $1 billion a year by 2030.
“They’re trying to ramp it quicker than they would have imagined six months ago,” said analyst Steven Fox of Fox Advisors LLC.
Valor could add sales growth while Corning’s older business of making glass for LCD screens, which accounted for $3.25 billion of the company’s $11.5 billion total sales last year, remains flat over the next couple of years, Mr. Fox said.
*Article written by Jared S. Hopking - The Wall Street Journal